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

Device Problems Burst Container or Vessel (1074); Overheating of Device (1437); Smoking (1585); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 07/20/2015

Event Type  malfunction  

Event Description

During turnover of the operating room, the battery pack of the used zimmer pulse a vac exploded.The battery pack then smoked and became very hot to the touch.The battery pack was brought to the main or desk after the incident.About a minute after it had been left at the desk, the pack made a noise like a firecracker and a fine black powder was expelled from the battery in an 18 inch radius.The pack was removed from the front desk until it was cool and then sequestered to be examined by clinical engineering.It was reported by the staff in the operating room that the wiring had been cut from the pack prior to it exploding.

• Brand Name: PULSAVAC
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 5155671
• MDR Text Key: 28455283
• Report Number: 5155671
• 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: Patient
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1