LIFE PACK 5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-11 for LIFE PACK 5 manufactured by Unknown.

Event Text Entries

[18449256] Two attempts were made to defibrillate the patient - device failed to produce the needed shock/joules. 71 year old patient expired, but had been down in field for possibly 30 minutes prior to resusciatative efforts being initiated. Invalid data - regarding single use labeling of device. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-93. Service provided by: invalid data. Service records available. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7544
• MDR Report Key: 7544
• Date Received: 1994-01-11
• Date of Report: 1993-10-15
• Date of Event: 1993-10-09
• Date Facility Aware: 1993-10-09
• Report Date: 1993-10-15
• Date Reported to Mfgr: 1993-10-15
• Date Added to Maude: 1994-04-29
• 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: LIFE PACK 5
• Generic Name: DEFIBRILLATOR
• Product Code: DRK
• Date Received: 1994-01-11
• ID Number: 09-00285-08 09-00283-14
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7223
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1994-01-11