MAUDE Adverse Event Report: INTEGRA YORK, PA INC. ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE; IMIG

Catalog Number	AX2100BIF
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Previously mfg report 2523190-2019-00013 filed with product id ax1375bif ancillary; however, the ax2100bif ultralite pro headlight was returned and evaluated.A visual inspection of the returned ax2100bif head band and luminaire only, found the back of the luminaire headlight bottom was partially melted and discolored.The mirror assembly inside the luminaire was broken and fragments were observed on the inner surface of the lens.The broken mirror assembly did not properly reflect the high intensity beam and resulted in the melted back section of the luminaire housing and dim light being emitted.The dhr review showed no manufacturing, workmanship, or material deficiency has been identified.The reported complaint was confirmed.The root cause was physically damaged consistent with rough handling, user error.Device identifier (b)(4).
Event or Problem Description
Initially mfg report 2523190-2019-00013 was filed with the product id ax1375bif ancillary.However, the product that was received and evaluated is the ax2100bif ultralite pro headlight w/premium cable.

• Brand Name: ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE
• Common Device Name: IMIG
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 8318925
• Report Number: 2523190-2019-00021
• Device Sequence Number: 1063761
• Product Code: FCW
• UDI-Device Identifier: 10381780168836
• UDI-Public: 10381780168836
• Combination Product (Y/N): N
• PMA/510(K) Number: K864380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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 Catalogue Number: AX2100BIF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1