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: BELIMED AG WASHER DISINFECTOR; CART WASHER
  • 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
 

BELIMED AG WASHER DISINFECTOR; CART WASHER Back to Search Results
Model Number CS750
Device Problems Break (1069); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
The cause of the malfunction has been identified as an end-of-life problem.At the time of the event, the washer had run 61,999 washing cycles, exceeding the manufacturer-defined life cycle of the device by 24%.
 
Event Description
In the central cleaning and sterilization department located on the second floor of a medical center, a pipe broke underneath the washer.Water leaked onto the floor and down into the first floor lobby.No adverse event occurred due to the malfunction, but if it were to recur hospital personnel could potentially slip, fall and be injured.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WASHER DISINFECTOR
Type of Device
CART WASHER
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 Key12180113
MDR Text Key264091736
Report Number3001061128-2021-00010
Device Sequence Number1
Product Code FLH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCS750
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-