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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB ENTROY LIFT, PATIENT, AC-POWERED

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ARJO HOSPITAL EQUIPMENT AB ENTROY LIFT, PATIENT, AC-POWERED Back to Search Results
Model Number GAB1011-01-GB
Device Problems Corroded ; Crack; Unstable; Device Tipped Over
Event Date 10/30/2019
Event Type  Injury  
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Brand NameENTROY
Type of DeviceLIFT, PATIENT, AC-POWERED
Manufacturer (Section D)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov 24121
SW  24121
Manufacturer (Section G)
ARJO HOSPITAL EQUIPMENT AB
verkstadsvagen 5
eslov, 24121
SW  24121
Manufacturer Contact
kinga stolinska
ul. ks. wawrzyniaka 2
komorniki,  62-05-2
  62-052
MDR Report Key9384519
Report Number3007420694-2019-00209
Device Sequence Number1
Product CodeFNG
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/27/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberGAB1011-01-GB
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/09/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 11/27/2019 Patient Sequence Number: 1
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