MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP POWER PACK, EXTENDED LIFE; HELMET, SURGICAL

Model Number 0408660000

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

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: 9 events were reported for this quarter.Product return status: 9 device investigation types have not yet been determined.9 devices were not labeled for single-use.9 devices were not reprocessed or reused.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.9 events had no patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: h6, h10.9 previously reported events are included in this follow-up record.Product return status: 9 devices were received.

Event Description

This report summarizes 9 malfunction events in which the device reportedly overheated.9 events had no patient involvement.No patient impact.

• Brand Name: POWER PACK, EXTENDED LIFE
• Type of Device: HELMET, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11728467
• MDR Text Key: 249679646
• Report Number: 3015967359-2021-00548
• Device Sequence Number: 1
• Product Code: FXZ
• UDI-Device Identifier: 04546540591654
• UDI-Public: 04546540591654
• Combination Product (y/n): N
• Number of Events Reported: 9
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0408660000
• Device Catalogue Number: 0408660000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1