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 Patient Involvement (2645)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

It was reported the exam light in or 2 fell off the ceiling-mounted suspension.Stryker gathered investigation details through email correspondence.From the investigation, it was determined that the light was past its life expectancy.A service history review was conducted, and it was found there were only two cases in which a stryker field service tech had examined the light for preventative maintenance or repair.The last visit to the light was for preventative maintenance in (b)(6) 2017.Although the exact root cause of the issue is unknown, the failure points towards lack of proper preventative maintenance by hospital personnel.Should new information emerge, a supplemental will be filed.There was no patient involvement, injury, or adverse consequence reported.Product end of life, unable to repair.

Event Description

It was reported that the exam light in or 2 fell off the ceiling-mounted suspension.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
• 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: 7802298
• MDR Text Key: 117852494
• Report Number: 0008010153-2018-00009
• Device Sequence Number: 1
• Product Code: KZF
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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