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

Catalog Number CE 2863075

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the light allegedly fell down during a procedure.A stryker field service technician (sfst) was dispatched to the customer site.The sfst reported that the light head did not fall off, but the spring arm disengaged from the horizontal arm.The retaining clip was found to be warped.It is unknown how the clip became warped.The light was repaired and returned to use.There was no injury or adverse consequence reported.

Event Description

It was reported that the light allegedly fell down during a procedure.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: AC-POWERED MEDICAL EXAMINATION LIGHT
• 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: 7074931
• MDR Text Key: 94102900
• Report Number: 0008010153-2017-00038
• 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: consumer,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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: 11/07/2017
• 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: Reuse
• Patient Sequence Number: 1