LIFEPAK 6S 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 1993-07-13 for LIFEPAK 6S N/A manufactured by Physio-control.

Event Text Entries

[18136335] Defibrillator would not dischargedevice not 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-jan-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, performance tests performed. Results of evaluation: invalid data. Conclusion: device evaluated and alleged failure could not be duplicated, other. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device discarded, device recalled by manufacturer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5854
• MDR Report Key: 5854
• Date Received: 1993-07-13
• Date of Report: 1993-06-22
• Date of Event: 1993-06-11
• Date Facility Aware: 1993-06-11
• Report Date: 1993-06-22
• Date Reported to FDA: 1993-06-22
• Date Reported to Mfgr: 1993-06-22
• Date Added to Maude: 1993-07-27
• 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 6S
• Generic Name: DEFIBRILLATOR
• Product Code: DRK
• Date Received: 1993-07-13
• Model Number: LIFEPAK 6S
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: 782 840
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5553
• Manufacturer: PHYSIO-CONTROL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1993-07-13