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)
Recall
- Recall Number
- Z-0760-2007
- Event Number
- 37607
- Firm
- Nellcor Puritan Bennett
- FEI Number
- 2936999
- Product Code
- CBK
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 12, 2007
- Posted
- April 24, 2007
- Terminated
- December 13, 2012
- Address
- 4280 Hacienda Dr, Pleasanton, CA, 94588-2719
Description
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)
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.
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.
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
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