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 Migration or Expulsion of Device (1395)

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

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the berchtold chromophare f 300 medical examination light has fallen off the hinge mount.The investigation is ongoing.Once the investigation is complete, a supplemental will be filed.There was no injury or adverse consequence reported.

Event Description

It was reported that the berchtold chromophare f 300 medical examination light has fallen off the hinge mount.There was no injury or adverse consequence reported.

Manufacturer Narrative

It was reported that a bulb burned out on an f300 exam light.The light then disengaged at the horizontal arm to spring arm joint, potentially due to a warped or displaced locking ring (also referred to as a c-clip).The light was repaired and functionality verified.There was no associated procedure and no surgical delay.While it is unknown how the locking ring became warped and/or displaced, this issue could have occurred during installation or during system maintenance.There was no injury or adverse consequence reported.

Event Description

It was reported that the berchtold chromophare f 300 medical examination light has fallen off the hinge mount.There was no injury or adverse consequence reported.

• 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
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; 74611810
• MDR Report Key: 7118208
• MDR Text Key: 95577544
• Report Number: 0008010153-2017-00039
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CE 2863075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• 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