LIFEPAC 9 MONITOR DEFIBRILATOR NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for LIFEPAC 9 MONITOR DEFIBRILATOR NA manufactured by Physio-control Corp..

Event Text Entries

[3880] Patient arrived code 3 to emergency department. C. P. R. In progress. Code blue team called upon arrival to emergency department. C. P. R. Continued with no response noted in patient progress. Patient was attached to lifepak 9 defibrillator/monitor and defibrillation cables. Patient was subsequently defibrillated 2 times. Upon the third times the defibrillator failed to accept a charge and was unusable. Patient was immediately transferred to an adjacent lifepak 10 defibrillator/monitor. Patient did not respond to treatment and subsequently expireddevice 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. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: electrical tests performed, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: component failure. Conclusion: other. Certainty of device as cause of or contributor to event: no. Corrective actions: device repaired and put back in service, device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5915
• MDR Report Key: 5915
• Date Received: 1993-07-01
• Date of Report: 1993-05-28
• Date of Event: 1993-03-18
• Date Facility Aware: 1993-03-18
• Report Date: 1993-05-28
• Date Reported to FDA: 1993-05-28
• Date Reported to Mfgr: 1993-03-18
• Date Added to Maude: 1993-07-29
• 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

• Product Code: DRK
• Date Received: 1993-07-01
• Model Number: LIFEPAC 9 MONITOR DEFIBRILATOR
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5613
• Manufacturer: PHYSIO-CONTROL CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-07-01