PHYSIO-CONTROL DEF.-LIFEPAK 8 PAD.-800505-03 NONE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for PHYSIO-CONTROL DEF.-LIFEPAK 8 PAD.-800505-03 NONE manufactured by Physio-control.

Event Text Entries

[2621] Lifepak defibrillator cassette - paramedics arrived at scene at 2324, pt with gun shot wound to heart. Pt in full arrest - cpr began. Pt arrived to hospital at 2339 in full arrest: cpr in progress - at 0012 - life pak used, defib paddles used, lifepak did not charge, defib paddles not labelled by manufacturer for use. Only with lifepak. Paddles fit both machines. Pt did not recover - coroner's casedevice not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jul-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed, visual examination. Results of evaluation: other. Conclusion: other. Certainty of device as cause of or contributor to event: no. Corrective actions: other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6322
• MDR Report Key: 6322
• Date Received: 1993-08-16
• Date of Report: 1993-07-19
• Date of Event: 1993-07-10
• Date Facility Aware: 1993-07-10
• Report Date: 1993-07-19
• Date Reported to FDA: 1993-07-19
• Date Reported to Mfgr: 1993-07-15
• Date Added to Maude: 1993-08-31
• 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
• Generic Name: DEFIBRILLATOR & ANTERIOR POSTERIOR PADDLES
• Product Code: DRK
• Date Received: 1993-08-16
• Model Number: DEF.-LIFEPAK 8 PAD.-800505-03
• Catalog Number: NONE
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6011
• Manufacturer: PHYSIO-CONTROL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-08-16