MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC®; LAVAGE, JET

Model Number 00-5150-475-00

Device Problems Burst Container or Vessel (1074); Device Emits Odor (1425); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/10/2017

Event Type  malfunction  

Event Description

Patient having left hemiarthroplasty secondary to left femoral neck displaced fracture.Zimmer pulsavac plus wound debridement system failed.The battery pack popped, smelled like it was burning and black dust came out of the battery pack.Manufacturer response for pulsavac plus wound debridement system, zimmer pulsavac battery pack (per site reporter).This product is in possession of sterile processing awaiting the return address from zimmer.

• Brand Name: PULSAVAC®
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio ave.; dover OH 44622
• MDR Report Key: 6614466
• MDR Text Key: 76841818
• Report Number: 6614466
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2017,04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-5150-475-00
• Device Catalogue Number: 00-5150-475-00
• Device Lot Number: 63494794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 73