MAUDE Adverse Event Report: ZIMMER PULSAVAC; WOUND IRRIGATION SYSTEM

Model Number 00-5150-475-00

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem No Information (3190)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

Upon end of case clean up, the battery pack to the pulsavac was disconnected and a hot electrical smell was noticed.The battery pack was very hot and "popping noises" were noted.Battery acid was also noted to be leaking from the batteries inside of the battery pack.Diagnosis or reason for use: right shoulder surgery.

• Brand Name: PULSAVAC
• Type of Device: WOUND IRRIGATION SYSTEM
• Manufacturer (Section D): ZIMMER; dover 44622
• MDR Report Key: 3893907
• MDR Text Key: 4676438
• Report Number: MW5036794
• Device Sequence Number: 1
• Product Code: FQH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 00-5150-475-00
• Device Catalogue Number: 00-5150-475-00
• Device Lot Number: 62647527
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR