MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 BATTERY CHARGER (230V); HELMET, SURGICAL

Catalog Number 0400655001

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2015

Event Type  malfunction  

Event Description

It was reported that prior to a medical procedure at the user facility the device was overheating.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: T4 BATTERY CHARGER (230V)
• Type of Device: HELMET, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5004536
• MDR Text Key: 23113468
• Report Number: 0001811755-2015-02932
• Device Sequence Number: 1
• Product Code: FXZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0400655001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2015
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1