PD1200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for PD1200 manufactured by Zoll.

Event Text Entries

[4494] Icu patient developed ventricular tachycardia, required defibrillation. After the fourth defibrillation, the ekg tracing disappeared from the screen. The defibrillator was immediately plugged into the nearest electrical outlet and exhibited a delay in re-charging. The patient required no further defibrillation. The defibrillator was removed from patient use. Bioengineering's evaluation revealed a battery pack failure as the direct cause of the delay in re-charging. The patient 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-may-93. Service provided by: user facility biomedical/bioengineering department. Service records available. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed. Results of evaluation: component failure, battery/pack. Conclusion: device failure directly caused event. 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: 6299
• MDR Report Key: 6299
• Date Received: 1993-08-16
• Date of Report: 1993-07-15
• Date of Event: 1993-06-24
• Date Facility Aware: 1993-06-24
• Report Date: 1993-07-15
• Date Reported to FDA: 1993-07-15
• Date Reported to Mfgr: 1993-07-15
• Date Added to Maude: 1993-08-30
• 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: 1993-08-16
• Model Number: PD1200
• ID Number: 16644
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: *
• Device Age: 01-DEC-91
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5988
• Manufacturer: ZOLL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-08-16