MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED

Model Number CH00000001

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the blue circular dome on the back of the f gen light head disengaged outside of a case.There were no reported injury or adverse consequences.The severity of this case is low, s0, per rsk12227.(b)(4) were opened to review and address this issue.This light is within scope of the field action.

Event Description

It was reported in or 3, a blue dome fell off an f528 light.There was no patient involvement or any reported adverse consequences.

• Brand Name: CHROMOPHARE OR LIGHT CEILING-MOUNTED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; DE 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; DE 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; DE 78532 ; 74611810
• MDR Report Key: 10024241
• MDR Text Key: 217445807
• Report Number: 0008010153-2020-00004
• Device Sequence Number: 1
• Product Code: FSY
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2020
• 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
• Removal/Correction Number: RES 83355
• Patient Sequence Number: 1