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

Catalog Number	0408660000
Medical Device Problem Codes	Fire (1245); Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame.The battery was removed from the flyte helmet and put into water in a sink.The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet.No patient involvement with this event.
Additional Manufacturer Narrative
Device not available for evaluation; however, images were provided for examination.Lot number and manufacture date updated.Correction: device code changed to reflect updated information provided.Device not returned; however, images were provided for examination.
Event or Problem Description
The user facility reported that when a flyte battery was connected to the flyte helmet prior to an operation, the battery began to smoke and later began to burn with a small flame.The battery was removed from the flyte helmet and put into water in a sink.The user facility also reported that the battery was dropped on the floor prior to connecting the battery with the helmet.No patient involvement with this event.

• Brand Name: POWER PACK, EXTENDED LIFE
• Common Device Name: HELMET, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8112138
• Report Number: 0001811755-2018-02570
• Device Sequence Number: 1693369
• Product Code: FXZ
• UDI-Device Identifier: 04546540591654
• UDI-Public: 04546540591654
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 0408660000
• Device Lot Number: 2017-07-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1