ZOLL PACEMAKER/DEFIBRILLATOR PD 1200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-09 for ZOLL PACEMAKER/DEFIBRILLATOR PD 1200 manufactured by Zoll Medical Corporation.

Event Text Entries

[3647] During resuscitation, defibrillation was required x3. As the defibrillator was being charged for a fourth time, it was noted that the paddles did not fully charge to the 300 joules. Nurse turned off power, turned it back on, paddles did charge to the 300 joules and defibrillator appeared to fully discharge. This resulted in a very slight delay but had no overall effect on the resuscitation event. Afterwards, "error 44" noted on screen. Defibrillator sent to biomedical electronics and will be sent to manufacturer for evaluation and repair. This defibrillator is located in ekg department and is rarely used but has been tested daily. Defibrillator was plugged in at the time. 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: 01-may-93. Service provided by: manufacturer. Service records available. 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, visual examination. Results of evaluation: component failure, discrete component/device. Conclusion: device failure occurred but not related to event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7495
• MDR Report Key: 7495
• Date Received: 1994-01-09
• Date of Report: 1993-10-14
• Date of Event: 1993-10-12
• Date Facility Aware: 1993-10-13
• Report Date: 1993-10-14
• Date Reported to Mfgr: 1993-10-14
• Date Added to Maude: 1994-04-26
• 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: ZOLL PACEMAKER/DEFIBRILLATOR
• Generic Name: PACEMAKER/DEFIBRILLATOR
• Product Code: DRK
• Date Received: 1994-01-09
• Model Number: PD 1200
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-SEP-90
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7174
• Manufacturer: ZOLL MEDICAL CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-01-09