MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO T4 HELMET POWER PACK; HELMET, SURGICAL

Catalog Number 0400650000

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2019

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device was not available for evaluation.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.Device not available for evaluation.

Event Description

This report summarizes 1 malfunction event in which the device reportedly overheated.1 event had no patient involvement; no patient impact.

• Brand Name: T4 HELMET POWER PACK
• 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 9245083
• MDR Text Key: 169215076
• Report Number: 0001811755-2019-03414
• Device Sequence Number: 1
• Product Code: FXZ
• UDI-Device Identifier: 04546540152534
• UDI-Public: 04546540152534
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0400650000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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