Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number CH00000001
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/26/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was reported that the cover separated from an f generation light.The light head reported is within the scope of pfa1937561 and will be handled accordingly.There was no patient involvement, no injuries, no adverse consequences or delay.Per rsk12227 revision e, the severity is s0.
 
Event or Problem Description
It was reported the dome cover fell off in r&d 2.There were no reported injuries.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CHROMOPHARE OR LIGHT CEILING-MOUNTED
Common Device Name
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
BERCHTOLD GMBH & CO. KG
ludwigstaler strasse 25
tuttlingen 78532
GM  78532
MDR Report Key12040484
Report Number0008010153-2021-00003
Device Sequence Number4198570
Product Code FSY
UDI-Device Identifier07613327296167
UDI-Public07613327296167
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date (Section B) 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberCH00000001
Device Catalogue NumberCH00000001
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/26/2021
Initial Report FDA Received Date06/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		RES 83355
Patient Sequence Number1
-
-