MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US; LIGHTING

Catalog Number 90520US

Device Problems Optical Problem (3001); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A biomedical technician reported that the light on the 90520us led headlight w/batteries & ac/dc power supply will dim after about 5 to 10 minutes of use.They believed that the board was heating up in the back, forcing the headset to dim.No surgery delay nor patient injury was reported.

Manufacturer Narrative

Additional information: d10, g4, g7, h2, h3, h6, h10 unique device identifier- (b)(4).The device was not returned for evaluation therefore the failure analysis and determination of root cause could not be completed due to a lack of information received.The customer cancelled repair and declined to return the product.The device history record (dhr) could not be completed as the serial number provided (led002261) does not appear to be valid.No other lot or serial number was provided during the investigation.The reported complaint was not confirmed.

Event Description

N/a.

• Brand Name: LED HEADLIGHT W/BATTERIES & AC/DC POWER SUPPLY - US
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• MDR Report Key: 10261230
• MDR Text Key: 203332138
• Report Number: 2523190-2020-00071
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 90520US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1