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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000
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ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000 Back to Search Results
Model Number AR32111-EU
Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Installation-Related Problem (2965)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2013
Event Type  No Answer Provided  
Event Description
Initially it was reported by arjohuntleigh representative that the tub was tipping during use when caregiver was holding the down button on bath.He stopped immediately, and raised the bath.When raising the bath the product stopped tipping and went back to all four feet on the floor.He emptied tub and lowered, and incident did not happen again.From the information received no injury occurred to the patient or caregiver.Patient was secured by sling when tub tipped (ceiling lift).Reference mfr # 9611530-2013-00166.
 
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Brand Name
SYSTEM 2000
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 2412 1
SW  24121
Manufacturer (Section G)
ARJO, INC.
50 north gary ave., suite a
roselle IL 60172 168
Manufacturer Contact
50 north gary ave., suite a
roselle, IL 60172-1684
MDR Report Key3610877
MDR Text Key4170873
Report Number1419652-2013-00369
Device Sequence Number1
Product Code ILM
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 12/13/2013
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
Device Operator Other
Device Model NumberAR32111-EU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2014
Distributor Facility Aware Date12/13/2013
Device Age11 NA
Event Location Nursing Home
Date Report to Manufacturer01/10/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/14/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age21 YR
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