MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; AC-POWERED MEDICAL EXAMINATION LIGHT

Catalog Number CH00000001

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported that an f300 exam light fell in operating room (or) 1, 5th floor.A stryker field service technician (sfst) was dispatched for investigation.The sfst entered the or and confirmed that both the exam light and the spring arm had detached from the horizontal arm and fell. upon further inspection the sfst found that there were deep scratches on the rear end spring arm post, near the groove where the spring arm circlip normally seats.It was also noted that there were no signs of collision of the exam light system with other equipment in the room.The sfst interviewed the hospital staff to inquire as to how this issue was discovered.He was told that a nurse saw the exam light fall onto the floor next to a patient who was sitting in an exam chair.The installation qip for the exam light was reviewed and the form showed that the unit was properly installed and passed final qc inspection on 27 june 2017.Although the spring arm and exam light fell while a patient was seated in the exam chair, there was no injury or adverse consequence reported.The investigation is still in progress, and stryker will file a supplemental once the investigation is complete.

Event Description

It was reported that a f300 light fell.There was no patient involvement, injury or adverse consequence reported.

Manufacturer Narrative

Although the exact root cause could not be determined, the most likely root cause of the falling spring arm and exam light would be downward force caused by misuse of the equipment.As was reported, this issue was discovered outside of a procedure, and there was no reported injury or adverse event.

Event Description

It was reported that a f300 light fell.There was no patient involvement, injury or adverse consequence reported.

• Brand Name: CHROMOPHARE OR LIGHT CEILING-MOUNTED
• Type of Device: AC-POWERED MEDICAL EXAMINATION LIGHT
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532
• MDR Report Key: 7720887
• MDR Text Key: 115364686
• Report Number: 0008010153-2018-00008
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1