MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. PULSAVAC PLUS AC WOUND DEBRIDEMENT SYSTEM; LAVAGE, JET

Model Number 00-5150-476-01

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

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

Event Date 05/14/2019

Event Type  malfunction  

Event Description

Zimmer pulsavac plus alternating current (ac) wound debridement system frequently stops working if more than two, 3 liter bags of irrigation solution are used during wound debridements.Operating room users report that after initiation of the third bag of irrigation solution, they frequently smell a "burning odor", and then the debridement system stops working.

• Brand Name: PULSAVAC PLUS AC WOUND DEBRIDEMENT SYSTEM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio ave.; dover OH 44622
• MDR Report Key: 8699436
• MDR Text Key: 148023834
• Report Number: 8699436
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/10/2019,05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-5150-476-01
• Device Catalogue Number: 00-5150-476-01
• Device Lot Number: 64159784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2019
• Date Report to Manufacturer: 06/14/2019
• Type of Device Usage: N
• Patient Sequence Number: 1