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Terminated

The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.

FDA Recall Z-1257-2017 · Posted 2017-03-03

Recalling FirmPhysio-Control, Inc.
Recall StatusTerminated
Product CodeMKJ
Date Initiated2017-01-13
Date Terminated2019-08-22
Product Quantitytotal 133,330 units (50,046 units in the US)

Reason for Recall

The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

Firm Action

Physio Control sent an Urgent Medical Device Correction letter dated January 2017 to all affected customers. The firm issued the press release on January 13, 2017. The link to press release is http://www.fda.gov/Safety/Recalls/ucm537114.htm. The firm also started mailing letter, confirmation sheet, check list to consignees on January 13, 2017. On August 28, 2017, the US begun contacting customers that have not yet responded to the previous mailings. Information about this notice is available at: www.physio-control.com/lifepak1000-274. Customers were instructed to immediately remove and reinstall the battery from their LIFEPAK 1000 defibrillator. The removal and reinstallation of the battery will clean the contacts of oxidation and will restore power to the device. It is critically important that customers implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices. Removing and reinstalling the battery on a weekly basis will help ensure their device is ready for use. Customers were also advised to always carry a spare, fully charged battery. The weekly schedule of battery removal must be performed until their device correction has been completed. Customers were asked to forward this information to all of their sites, trainers and users who have LIFEPAK 1000 devices. The Customer Letter was updated on the web page to clarify the statement "It is also important to always carry a spare, fully charged battery" was provided as a reminder to customers and is consistent with what is stated in the LIFEPAK 1000 Defibrillator Operating Instructions. Customers were asked to complete and return the Confirmation Sheet to Physio-Control. Customers with questions regarding this notification, please contact Physio-Control by calling 1-866-231-1220, 6:00 a.m. to 4:00 p.m. (Pacific) Monday Friday, or by email to [email protected] or fax to 1-866-448-9567. **************************************

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122600LIFEPAK 1000 DEFIBRILLATORPhysio-Control, Inc. · 2012-10-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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