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 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the light allegedly fell due to the spring arm and horizontal arm separating.The stryker field service technician (sfst) stated that he was provided photos and a statement from the customer that the spring arm disengaged from the horizontal arm.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 light allegedly fell due to the spring arm and horizontal arm separating.There was no injury or adverse consequence reported.

Manufacturer Narrative

It was reported that an f300 light separated at the spring arm to horizontal arm joint.The connection point was damaged.While it is unknown how the damage occurred, potential root causes could be maintenance of the system by non-stryker personnel (for example, the p3 maintenance company employed by the hospital).The light has been replaced at the site by a stryker field service technician.

Event Description

It was reported that the light allegedly fell due to the spring arm and horizontal arm separating.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: 7054443
• MDR Text Key: 93110396
• Report Number: 0008010153-2017-00037
• 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: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• 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: 11/02/2017
• 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