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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS N. V. ARJO SARA 3000; SIT TO STAND LIFT

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MEDIBO MEDICAL PRODUCTS N. V. ARJO SARA 3000; SIT TO STAND LIFT Back to Search Results
Model Number 2008
Device Problem Material Integrity Problem (2978)
Patient Problem Vertebral Fracture (4520)
Event Date 09/24/2021
Event Type  Death  
Event Description
Stna nursing aide utilized arjo 3000 to raise pt with lift remote per typical practice when lift malfunctioned causing bf to fall off lift and hit head on dresser.Lpn initial reporter came to assist, called 911 and tended to laceration to b.F's posterior scalp.Ems transferred to hosp who indicated he had a likely closed nondisplaced fracture of the sixth cervical vertebra.According to hosp, palliative care was consulted for symptom mgmt, and family opted for hospice care.
 
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Brand Name
ARJO SARA 3000
Type of Device
SIT TO STAND LIFT
Manufacturer (Section D)
MEDIBO MEDICAL PRODUCTS N. V.
heikant 5
harmont-achel BE-39 30
MDR Report Key12624274
MDR Text Key276402152
Report Number12624274
Device Sequence Number1
Product Code FSA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/07/2021
Distributor Facility Aware Date09/24/2021
Device Age13 YR
Event Location Nursing Home
Date Report to Manufacturer10/07/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age100 YR
Patient Weight88
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