LIFEPAK 10 MONITOR/DEFIBRILLATOR FAST PATCH ADAPTOR 80509Y-01 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-23 for LIFEPAK 10 MONITOR/DEFIBRILLATOR FAST PATCH ADAPTOR 80509Y-01 N/A manufactured by Physio Control Corperation.

Event Text Entries

[6845] 72 year old female who received defibrillation from a lifepak 10 fast patch adaptor. The defibrillation electrodes were placed on the patient and the patient received a total of nine (9) defibrillations at various energy levels. When the apex electrode was removed, it was noted that the patient has received a partial/full thickness burn to the left axillary anterior chest wall as a direct result defibrillation with the fast patch adaptor electrode. This piece of equipment was removed from service immediately and was inspected by the service representative. No problems were found with this equipment. Device labeled for single use. 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-mar-92. Service provided by: factory trained/authorized/owned service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8972
• MDR Report Key: 8972
• Date Received: 1993-07-23
• Date of Event: 1992-10-20
• Date Facility Aware: 1992-10-20
• Date Reported to Mfgr: 1992-10-20
• Date Added to Maude: 1994-11-04
• 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: LIFEPAK 10 MONITOR/DEFIBRILLATOR FAST PATCH ADAPTOR
• Product Code: DRK
• Date Received: 1993-07-23
• Model Number: 80509Y-01
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUN-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8632
• Manufacturer: PHYSIO CONTROL CORPERATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1993-07-23