MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 EIGHT STATION BATTERY CHARGER 120 V; HELMET, SURGICAL

Catalog Number	0400655000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device overheated during testing.There were no reported adverse consequences; there were no procedure delays; there was no medical intervention required.The procedure was completed successfully.

• Brand Name: T4 EIGHT STATION BATTERY CHARGER 120 V
• Common Device Name: HELMET, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7654565
• Report Number: 0001811755-2018-01119
• Device Sequence Number: 11039917
• Product Code: FXZ
• UDI-Device Identifier: 04546540903839
• UDI-Public: 04546540903839
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 0400655000
• Device Lot Number: 0609100153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1