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 Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that in room 2016, the f300 exam light would not power on.A stryker field service technician (sfst) was dispatched for investigation.The sfst entered the room and found that the spring arm was unseated from the horizontal arm.Upon further inspection, the sfst found a loose spring arm circlip, which is used to secure the spring arm to the horizontal arm of the exam light system.The technician proceeded to reseat the spring arm, ensuring that is was secure by properly installing the spring arm circlip.A functional test was performed and the equipment was found to be working to specification.The equipment was then returned back to service and the issue was resolved.The sfst interviewed the hospital staff to determine how the keeper clip became missing.None of the hospital staff knew how the issue happened or if another vendor had been performing maintenance on the equipment.There was no installation qip found as it was reported that the exam light system was installed by the customer.The service history for the suspension was also reviewed.There was one service ticket found for this exam light system.Sales force case (b)(4) was opened back on 20 july 2016 for a reported issue of the f300 light not powering on.The sfst assigned to this case found the root cause to be a mis-seated spring arm circlip.Trackwise complaint (b)(4) was opened to investigate this issue further.In conclusion, it was determined that the root cause was improper maintenance by hospital personnel, as it was reported that the in-house biomedical department performs all service and maintenance.Although the exact root cause of this issue is unknown, the most likely root cause would be improper service and maintenance by hospital personnel.The investigation is still ongoing, and an update will be provided if new information becomes available.There was no injury or adverse event reported.

Event Description

It was reported that in room 2016, the f300 exam light would not power on.A stryker field service technician (sfst) was dispatched for investigation.The sfst entered the room and found that the spring arm was unseated from the horizontal arm.There were no injuries or adverse consequences.

• 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: 8541322
• MDR Text Key: 151936286
• Report Number: 0008010153-2019-00004
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 07613327296198
• UDI-Public: 07613327296198
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CE 2863075
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2019
• 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