MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG SINGLE FLAT PANEL ARM, 26IN, 8.5-12KG; DEVICE, MEDICAL EXAMINATION, AC POWERED

Catalog Number CT 0602604

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that in or 16, there was a gap present between the berchtold flat panel spring arm and flat panel carrier.A stryker field service technician (sfst) was dispatched for investigation.The sfst entered the or and confirmed that a gap was present at the safety segment section, where the flat panel carrier attaches to the spring arm.Upon further inspection the sfst removed the monitor from the flat panel carrier and then tried to remove the screw that holds the blue safety segment cover in place.Once the screw was removed, he found that the keeper clip, which is used to keep the flat panel yoke attached to the spring arm, was missing.He found that the safety segment screw that keeps the blue safety segment cover in place had been used as a substitute for the keeper clip.The sfst then proceeded reinstall the yoke onto the spring arm, and then install a new keeper clip into the safety segment area.A functional test was performed to ensure the yoke was properly secured to the spring arm.The equipment was found to be working to specification, and there was no excessive gap present.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, as there was competitor integration, a competitor flat panel monitor, and competitor video cabling installed in the same or.The installation qip for the surgical light system was reviewed and the form showed that the unit was properly installed and passed final qc inspection on 10 may 2016.The service history for the suspension was also reviewed, and there were no service tickets found, indicating that the suspension has not been serviced by stryker personnel since installation.Although the exact root cause of this issue is unknown, the most likely root cause would be improper service and maintenance by hospital personnel.There was no injury or adverse event reported.

Event Description

It was reported that in or 16, there was a gap present between the berchtold flat panel spring arm and flat panel carrier.It was found the suspension was missing a keeper clip.There were no injuries or adverse consequences.

• Brand Name: SINGLE FLAT PANEL ARM, 26IN, 8.5-12KG
• 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: 8289490
• MDR Text Key: 136988303
• Report Number: 0008010153-2019-00001
• Device Sequence Number: 1
• Product Code: KZF
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CT 0602604
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2019
• 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