R2 PADS 610 ADULT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-04 for R2 PADS 610 ADULT manufactured by R2 Medical Systems, Inc.

Event Text Entries

[18169505] Hands off defib pad sparked when defibrillator discharged. Pads were properly placed. Anterior/posterior. Lifepak 10 defibrillator used. Sparking noticed at site where wires go into pad. Defibrillations delivered. Coverted v-fib to asystole. Upon examination of pads, noted craking of conductive material. Device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. 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, a device from same lot was evaluated, electrical tests performed, visual examination. Results of evaluation: material degradation/deterioration, telemetry failure, unanticipated short term complication of procedure, electrode failure. Conclusion: device failure occurred but not related to event, device unavailable for follow-up investigation examination. Certainty of device as cause of or contributor to event: invalid data. 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: 7735
• MDR Report Key: 7735
• Date Received: 1994-02-04
• Date of Report: 1993-11-15
• Date of Event: 1993-11-09
• Date Facility Aware: 1993-11-09
• Report Date: 1993-11-15
• Date Reported to Mfgr: 1993-11-10
• Date Added to Maude: 1994-05-16
• 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: R2 PADS
• Generic Name: ELECTRODE PAD DEFIB/PACING
• Product Code: DRK
• Date Received: 1994-02-04
• Model Number: 610 ADULT
• Catalog Number: 610 ADULT
• Device Expiration Date: 1995-04-01
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-OCT-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 7414
• Manufacturer: R2 MEDICAL SYSTEMS, INC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-02-04