LIFE PAK 9 803800-18

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-11 for LIFE PAK 9 803800-18 manufactured by Physio-control Corporation.

Event Text Entries

[5207] Lifepack 9 being used during code, patient was defibrillated 3 times, paddles were replaced back into paddle holders in order to continue cpr. Paddles were removed to attempt a 4th discharge, it was then noted that the discharge button was missing. Another crash cart was utilized to contune resuscitation efforts. Staff also reported that the button had previously "popped off". Device 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:. Service provided by: invalid data. Invalid data - service records availability. 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, electrical tests performed, mechanical tests performed, performance tests performed. Results of evaluation: control switches/knobs/toggles. Conclusion: device failure occurred and was related to event, device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9806
• MDR Report Key: 9806
• Date Received: 1994-11-11
• Date of Report: 1994-02-23
• Date of Event: 1994-02-16
• Date Facility Aware: 1994-02-16
• Report Date: 1994-02-23
• Date Reported to Mfgr: 1994-02-23
• Date Added to Maude: 1995-01-30
• 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

• Generic Name: DEFIBRILLATOR/MONITOR
• Product Code: DRK
• Date Received: 1994-11-11
• Model Number: LIFE PAK 9 803800-18
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 9458
• Manufacturer: PHYSIO-CONTROL CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-11-11