MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05

Model Number 90620US

Device Problem Overheating of Device (1437)

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

Event Type  malfunction  

Event Description

It was reported that the nursing staff observed that the duo headlight (90620us) was flickering on and off during start up test and did not get any better when battery was changed out.The facility has not reported if there was patient involvement, injury or surgical delay related to this event.However; evaluation showed that the light was flickering because the unit was overheating.

Manufacturer Narrative

Duo headlight system (90620us) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported issue.Failure analysis: upon evaluating this unit, it was observed that when the unit is powered on, the fan turns off/on whenever the end of the power cord is moved.There was an short at the end of the cord that is causing the fan to turn off/on, which will cause the light to flicker because of the unit overheating; the power cord has been replaced to correct this issue.Root cause: the reported complaint is confirmed.The returned 90620us headlight is in used condition with damage to the power cord due to rough handling/environmental damage.The issue of a short refers to this damage.No additional risk was incurred by this damage.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: DUO HEADLIGHT 2 BAY SYSTEM - US
• Type of Device: PFM05
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14167816
• MDR Text Key: 299000072
• Report Number: 3006697299-2022-00057
• Device Sequence Number: 1
• Product Code: FSR
• UDI-Device Identifier: 10381780490746
• UDI-Public: 10381780490746
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2022

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 Model Number: 90620US
• Device Catalogue Number: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1