MAUDE Adverse Event Report: ZIMMER SURGICAL PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN

Catalog Number 00-5150-475-00

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported that during the surgery the batteries of the zimmer pulsavac plus exploded.The explosion occurred far away from patient and there was no delay.Additional clinical information indicated that there was no injury to the patient or hospital staff associated with this report.There was no report of surgical delay.The device was discarded by the hospital following the event.No additional clinical information was received prior to this report.

Manufacturer Narrative

The device was discarded by the hospital following the event; therefore, the device was not returned to the manufacturer for evaluation.Without the return of the device, the reported incident cannot be confirmed.Subsequently, any analysis to determine subcomponent failures or addressing corrective action cannot be initiated.The explosion of the batteries is the spontaneous expulsion of the battery anode.This would most likely occur when there is a short introduced into the power supply.There are too many variables involved that could cause the batteries to overheat, or to short out to adequately speculate on the cause for this incident.Any one of the warning conditions listed in the instructions for use (ifu) could account for the battery anode expulsion.

• Brand Name: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM FAN
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio ave.; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio ave.; dover, OH 44622 ; 3303438801
• MDR Report Key: 4403501
• MDR Text Key: 5121804
• Report Number: 1526350-2015-00003
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2017
• Device Catalogue Number: 00-5150-475-00
• Device Lot Number: 62766841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1