PHYSIO-CONTROL LIFEPAK 6 MONITOR/DEFIBRILLATOR LIFEPAK 6 S'

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-28 for PHYSIO-CONTROL LIFEPAK 6 MONITOR/DEFIBRILLATOR LIFEPAK 6 S' manufactured by Physio-control.

Event Text Entries

[19783534] During angiogram, patient fibrillated. Defibrillator would not emit charge. Another defibrillator was used to defibrillate patient. Patient stabilized. Internal evaluation revealed a defective power transistor and two internal blown fuses. Device 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-may-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: electrical tests performed, performance tests performed, visual examination. Results of evaluation: electrical problem - open circuit, environmental factors, power supply. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service, device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7599
• MDR Report Key: 7599
• Date Received: 1994-01-28
• Date of Report: 1993-08-24
• Date of Event: 1993-07-28
• Date Facility Aware: 1993-08-12
• Report Date: 1993-08-24
• Date Reported to Mfgr: 1993-08-24
• Date Added to Maude: 1994-05-04
• 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: PHYSIO-CONTROL LIFEPAK 6 MONITOR/DEFIBRILLATOR
• Generic Name: DEFIBRILLATOR
• Product Code: DRK
• Date Received: 1994-01-28
• Model Number: LIFEPAK 6 S'
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7278
• Manufacturer: PHYSIO-CONTROL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-01-28