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  

Manufacturer Narrative

The suspected duo headlight 2 bay system (90620us) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: the depot technician found that during evaluation of the duo headlight, the unit failed the spot size and uniformity test.The technician also noted that the fan was not working properly.The duo headlight will be sent to the supplier for repair and returned to the customer.Root cause analysis: the returned duo headlight was in used condition with a failing/damaged luminaire due to wear.The complaint reported by the customer was confirmed.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

A facility reported that the duo headlight 2 bay system (90620us) started blinking.The biomedical technician verified that after a few minutes the lamp alternates between dim and bright.The technician observed what seemed to be excessive heat and the cooling fan operation could not be seen nor heard.It is unknown under which circumstance this event occurred; however, no patient injury, death or surgical delay was reported.

• 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: 15449451
• MDR Text Key: 306088978
• Report Number: 3006697299-2022-00126
• 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: 09/19/2022

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: Other
• Device Model Number: 90620US
• Device Catalogue Number: 90620US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/19/2022
• 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