PHYSIO CONTROL/LIFE PAK 5 9-00285-08 LIFE PAK 5 9-00285-08

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-08 for PHYSIO CONTROL/LIFE PAK 5 9-00285-08 LIFE PAK 5 9-00285-08 manufactured by Physio Control.

Event Text Entries

[3774] A 51 year old patient with iddm, adhesive pericariditis, s/p cabg, posterior wall mi, chf, crf, acvd, and bilaterial pulmonary atelectasis coded on 5/2/93. Code team responded with life pak 5, inclusive of defibrillator and monitor both manufactured. Patient was to be defibrillated and 1st battery showed low charge; 2nd battery dead. Battery backup obtained from the ep and patient defibrillated. Physician involved in code and on the safety committee evaluated the medical record and event, and could not determine user error or equipment failure or wheter the device contributed to the death. Life pak pulled from service and batteries #3 and #7 were unable to discharge a current. Battery charger checked. Batteries charged and fired for defibrillator properly. Two different batteries were available for use at that time. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-apr-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: design - human factors, mechanical problem, incorrect technique/procedure, patient's condition - predisposed event, battery/pack, ekg/ecg subassembly. Conclusion: device failure occurred and was related to event, device evaluated and alleged failure could not be duplicated, no failure detected but product out of specification. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service, user education provided, inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6364
• MDR Report Key: 6364
• Date Received: 1993-08-31
• Date of Report: 1993-07-26
• Date of Event: 1993-05-02
• Date Facility Aware: 1993-07-06
• Report Date: 1993-07-26
• Date Reported to FDA: 1993-07-26
• Date Reported to Mfgr: 1993-07-13
• Date Added to Maude: 1993-09-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PHYSIO CONTROL/LIFE PAK 5
• Generic Name: DEFIBRILLATOR
• Product Code: DRK
• Date Received: 1993-09-08
• Model Number: 9-00285-08 LIFE PAK 5
• Catalog Number: 9-00285-08
• Lot Number: NA
• ID Number: 2409
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-87
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6053
• Manufacturer: PHYSIO CONTROL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-31