MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-; DEVICE, MEDICAL EXAMINATION, AC POWERED

Catalog Number	CE 2863075
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the f300 was hanging by a cable and needed re-installed.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the f300 was hanging by a cable and needed re-installed.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported by the field service technician (fst) that this event took place in an exam room in the er and there was a combative patient in the room.The light was used as a weapon, and the screw that holds the arms together was disconnected by the patient.The fst visited the account and reported reassembling the device, securing the arms with a new screw and restoring full functionality.However, the customer would be ordering a replacement.The manufacturing dhr for the device was reviewed.The document shows all passing results.According to the intake information, there was no adverse event reported and this event occurred outside of surgery.The root cause is traced to a combative patient in the room and light being used as a weapon, which does not follow the intended use for this light (as outlined in the chromophare f300 exam light operating manual).This failure mode has not exceeded any thresholds and will continue to be monitored.If any further information is received, a supplemental will be filed.

• Brand Name: EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-
• Common Device Name: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: josh phillips ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 18917794
• Report Number: 0008010153-2024-00006
• Device Sequence Number: 12452663
• Product Code: KZF
• UDI-Device Identifier: 07613327296198
• UDI-Public: 07613327296198
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/04/2024

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: Other
• Device Catalogue Number: CE 2863075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown