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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BELIMED AG BELIMED WASHER/DISINFECTOR WD250
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BELIMED AG BELIMED WASHER/DISINFECTOR WD250 Back to Search Results
Model Number WD250
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2022
Event Type  malfunction  
Event Description
The pressure sensor of the washer overheated and temporarily emitted white smoke, which was witnessed by cssd personnel.
 
Manufacturer Narrative
After locating the source of the white smoke, the scorched pressure switch was replaced.The device was tested and it was confirmed that the issue had been resolved.Manufacturing history of the device was reviewed.No issues were found.The device was installed at the healthcare facility in 2015 and has been in use since then.Further investigation revealed that due to poor hospital maintenance of its water supply system, a water shutoff valve rusted and became leaky.Water began to drip on the pressure switch of the affected device, eventually leading to the incident.
 
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Brand Name
BELIMED WASHER/DISINFECTOR WD250
Type of Device
WASHER/DISINFECTOR
Manufacturer (Section D)
BELIMED AG
grienbachstrasse 11
zug, zug 6300
SZ  6300
Manufacturer (Section G)
BELIMED AG
grienbachstrasse 11
zug, zug 6300
SZ   6300
Manufacturer Contact
heidi friesacher
grienbachstrasse 11
zug, zug 6300
SZ   6300
MDR Report Key15945402
MDR Text Key306358680
Report Number3001061128-2022-00013
Device Sequence Number1
Product Code MEC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Remedial Action Repair
Type of Report Initial
Report Date 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberWD250
Device Lot Number998751029011
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/04/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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