MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FLYTE 120V BATTERY CHARGER; ACCESSORY, SURGICAL APPAREL

Model Number	0408655000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the user facility, the charger overheated and the rubber pads melted.There was no medical intervention and no adverse consequences with this event.As this event occurred during inspection at the user facility, there was no patient involvement and no delay to a surgical procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
It was reported that at the user facility, the charger overheated and the rubber pads melted.There was no medical intervention and no adverse consequences with this event.As this event occurred during inspection at the user facility, there was no patient involvement and no delay to a surgical procedure.

• Brand Name: FLYTE 120V BATTERY CHARGER
• Common Device Name: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9647426
• Report Number: 0001811755-2020-00354
• Device Sequence Number: 14096814
• Product Code: LYU
• UDI-Device Identifier: 07613154886289
• UDI-Public: 07613154886289
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: Health Professional
• Device Model Number: 0408655000
• Device Catalogue Number: 0408655000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1