ZOLL PD1400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-27 for ZOLL PD1400 manufactured by Zoll Medical Instruments Corp..

Event Text Entries

[3235] The patient was being transferred from our emergency room to another acute care facility. The patient had on pacer/defibrillator pads, the pacemaker/defibrillatory was properly attached to pads. Patient went into vt/vf while being transported by ambulance. The defibrillator was turned on, charged to 200 joules, and would not discharge , pads were removed and patient was defibrillated with the ambulance defibrillator successfully. The defibrillator was tested by our biomedical engineer and the problem could not be replicated. The manufacturer was removed the piece for equipment for testing and we will await their response. 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: 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: telemetry failure, invalid data. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor, device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7655
• MDR Report Key: 7655
• Date Received: 1994-01-27
• Date of Report: 1993-08-30
• Date of Event: 1993-08-11
• Date Facility Aware: 1993-08-12
• Report Date: 1993-08-30
• Date Reported to Mfgr: 1993-08-17
• Date Added to Maude: 1994-05-05
• 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
• Generic Name: DEFIBRILLATOR/EXTERNAL PACER/MONITOR
• Product Code: DRK
• Date Received: 1994-01-27
• Model Number: PD1400
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-OCT-92
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7334
• Manufacturer: ZOLL MEDICAL INSTRUMENTS CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-01-27