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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-10-23 for * manufactured by Zoll Circulation.

Event Text Entries

[4142837] Intraoperatively went to defibrillate patient, defibrillator charged to 30 joules; however, failed to discharge when button was pressed. A second set of defibrillator paddles were placed onto the surgical field and a second attempt to defibrillate the patient was attempted with a similar failed result. The defibrillator was tested prior to the start of surgery and again after switching out the defibrillator which showed test ok. Time between the initial failed first attempt and the successful defibrillation with new paddles and defibrillator was approximately three minutes. The patient was in v-tach for the entire time. Bio med interrogating the defibrillator. Defibrillator found to have a bent pin on a permanent cable. Unit pulled from service, new cable ordered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	3590850
MDR Report Key	3590850
Date Received	2013-10-23
Date of Report	2013-10-23
Date of Event	2013-10-09
Report Date	2013-10-23
Date Reported to FDA	2013-10-23
Date Reported to Mfgr	2014-01-24
Date Added to Maude	2014-01-24
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	3
Health Professional	3
Initial Report to FDA	3
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	*
Generic Name	DEFIBRILLATOR
Product Code	DRK
Date Received	2013-10-23
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	N
Device Age	*
Device Sequence No	1
Device Event Key	0
Manufacturer	ZOLL CIRCULATION
Manufacturer Address	2000 RINGWOOD AVE SAN JOSE CA 95131 US 95131

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-10-23