Puritan Bennett 840 Ventilator System, Catalogue Numbers: 4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP (Note: the Xs indicate any combination of alpha characters which specify option and language packs)
FDA Recall Z-0760-2007 · Posted 2007-04-24
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Recalling FirmNellcor Puritan Bennett
Recall StatusTerminated
Product CodeCBK
Date Initiated2007-03-12
Date Terminated2012-12-13
Product Quantity3756
Reason for Recall
In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.
Firm Action
The correction will extend to the end user. All users will be contacted by mail or through personal contact. In the U.S., all customers were mailed the 'Urgent Device Correction' letter along with a serial number listing of those units which records show were consigned to them beginning on March 12, 2007.
The customer communication informs customers of the issue and provides instruction for continued safe use of the device pending the correction.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHILE, COLOMBIA, EGYPT, FRANCE, GERMANY, GREECE, GUATEMALA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, LEBANON, MEXICO, MOROCCO, NICARAGUA, PANAMA, POLAND, PUERTO RICO, ROMANIA, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, TURKEY, UK, & YUGOSLAVIA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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