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

Catalog Number 00-5150-482-00

Device Problems Fire (1245); Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2015

Event Type  malfunction  

Event Description

It was reported that after surgery, the staff were tidying the theatre and cut the flex connecting the zimmer pulsavac plus hand unit with the battery pack.This was put on one side while staff continued in their duties.After a short while, the battery pack exploded, narrowly missing the face of one of the nurses, and caught fire.The fire was extinguished with water and the unit disposed of.No danger to patient, but significant danger to nurse and hospital property.No actual harm to the nurse, patient or hospital staff occurred as a result of the reported event.

Manufacturer Narrative

The product was not returned for evaluation.As such, confirmation of this complaint cannot be determined.However, the customer did report that during clean up the staff had cut the battery pack wiring and set it aside.Shortly thereafter the battery pack exploded and started a small fire in the operating room.The potential for the batteries to explode has been addressed in the ifu and in the risk assessment.The device instructions for use and the labeling on the tyvek lid warn that cutting the battery pack cable could lead to shock, excessive heat and / or sparks, and could result in fire or personal injury.The batteries should be physically removed from the battery pack, care should be taken and personal safety equipment should be worn.The most likely cause for this incident is improper disposal of the device in contradiction of the ifu warnings.

• Brand Name: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM HIP
• Type of Device: PULSAVAC PLUS WOUND DEBRIDEMENT SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: kathleen smith ; 200 west ohio avenue; dover, OH 44622 ; 3303438801
• MDR Report Key: 4890838
• MDR Text Key: 6020861
• Report Number: 1526350-2015-00115
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2015

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 Catalogue Number: 00-5150-482-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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