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

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that the f300 was hanging by a cable and needed re-installed.There were no reported injuries or adverse consequences.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

• Brand Name: EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-
• Type of Device: 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
• MDR Text Key: 337847736
• Report Number: 0008010153-2024-00006
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 07613327296198
• UDI-Public: 07613327296198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CE 2863075
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1