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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL PHYSIO CONTROL LIFEPAK NICD BATTERY 1.6AH LIFEPAK 12 BATTERY

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PHYSIO-CONTROL PHYSIO CONTROL LIFEPAK NICD BATTERY 1.6AH LIFEPAK 12 BATTERY Back to Search Results
Lot Number 1015
Event Date 04/27/2010
Event Type  Injury  
Event Description

Physio control battery malfunction - in the middle of providing patient care the physio control monitor was attached to the patient and was turned on, after approximately 1 minute the monitor shut off. The batteries were swapped out and the monitor functioned properly. After returning from the call, the batteries were put into the charger and they came up as "discard. " these were brand new batteries that were received from physio control on (b) (6) 2010 and were checked in the morning of the call and showed a full charge. This is approximately the 20th battery that has came up as discard and the third time that it failed in the middle of usage. Dates of use: (b) (6) 2010 - (b) (6) 2010. Diagnosis or reason for use: cardiac monitor during patient care.

 
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Brand NamePHYSIO CONTROL LIFEPAK NICD BATTERY 1.6AH
Type of DeviceLIFEPAK 12 BATTERY
Manufacturer (Section D)
PHYSIO-CONTROL
11811 willows rd ne
redmond WA 98052
MDR Report Key1672749
Report NumberMW5015728
Device Sequence Number1
Product CodeMOQ
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 04/28/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/28/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number1015
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 04/28/2010 Patient Sequence Number: 1
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