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

Model Number 5150-475

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/20/2014

Event Type  malfunction  

Event Description

Zimmer pulsavac plus wound debridement system tested on sterile field as part of case setup and determined to be non-functioning.Replaced with "like" device which functioned without problems.Diagnosis or reason for use: orif right hip.

• Brand Name: PULSAVAC PLUS
• Type of Device: WOUND DEBRIDEMENT SYSTEM
• Manufacturer (Section D): ZIMMER SURGICAL; dover OH 44622
• MDR Report Key: 3599234
• MDR Text Key: 4164521
• Report Number: MW5034004
• 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: 01/21/2014

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: 09/30/2016
• Device Model Number: 5150-475
• Device Catalogue Number: 5150-475
• Device Lot Number: 62499983
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR