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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE
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ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000; BATH, HYDRO-MASSAGE Back to Search Results
Model Number AP01201-GB
Device Problem Device Fell (4014)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Event Description
Arjo has been notified about the incident with involvement of system 2000.The customer stated that the bath dropped suddenly on the caregiver¿s foot whilst she was washing bed covers in bath.The bath was half filled with water at this time.Another carer attended and lifted bath off her foot.The customer facility stated that the carer fractured her big toe.The injured carer attended a&e department.According to the information from the customer facility, their in house investigation did not identify any issues with the device.They were not able to establish how this accident could have happened and why the bath would have dropped.
 
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Brand Name
SYSTEM 2000
Type of Device
BATH, HYDRO-MASSAGE
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 24121
SW  24121
MDR Report Key10137663
MDR Text Key194619174
Report Number1419652-2020-00029
Device Sequence Number1
Product Code ILJ
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberAP01201-GB
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2020
Distributor Facility Aware Date06/04/2020
Device Age18 YR
Event Location Nursing Home
Date Report to Manufacturer06/10/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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