CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.
FDA Recall Z-2554-2014 · Posted 2014-08-26
Advertisement
Recalling FirmCurbell Medical, Inc.
Recall StatusTerminated
Product CodeKMI
Date Initiated2014-08-05
Date Terminated2017-02-28
Product QuantityDomestic: 112 units; Foreign: 211 units
Reason for Recall
The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.
Firm Action
Urgent Medical Device Recall Letters (dated 8/01/14) and Response Forms were sent to the consignees via e-mail (w/read receipt) on 8/05/14.
Root Cause
Component design/selection
Distribution Pattern
Nationwide, Canada, Ireland, Italy
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement