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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPAN-AMERICA MEDICAL SYSTEMS SAVARIA FIXED LIFT; CEILING LIFT
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SPAN-AMERICA MEDICAL SYSTEMS SAVARIA FIXED LIFT; CEILING LIFT Back to Search Results
Model Number M929201
Device Problem Material Separation (1562)
Patient Problems Bruise/Contusion (1754); Fall (1848)
Event Date 03/21/2022
Event Type  Injury  
Event Description
During a transfer from bedroom and bathroom in patient's home, the carry bar separated while lifting the patient.Patient (female with cerebral palsy) was admitted to the hospital for observation given the fall and preexisting condition.The dealer suspected that the spreader bar is being taken in the shower and never disconnected based on substantial soap residue/rust at connection point.The investigation is ongoing.
 
Manufacturer Narrative
The lift and carry bar were investigated.The invetigation demonstrated the following: the unit has been repeatedly misused and not periodically inspected.The original design is suitable for its intended use; dry environment.The original user manual has instructions for intended use, cleaning and agents allowed, environmental conditions, preventative maintenance schedule the original design, despite submitted to aggressive environmental conditions remained safe and supported load far beyond the minimum safety factors field samplings (58 in total from few sites, all same age, all wet environment) were investigated.No observations of similar corrosion.Min 400h salt spray tests + durability tests 20y + ultimate strength tests.All pass above safety factor.
 
Event Description
During a transfer from bedroom and bathroom in patient's home, the carry bar separated while lifting the patient.Patient (female with cerebral palsy) was admitted to the hospital for observation given the fall and preexisting condition.The dealer suspected that the spreader bar is being taken in the shower and never disconnected based on substantial soap residue/rust at connection point.The investigation is ongoing.
 
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Brand Name
SAVARIA FIXED LIFT
Type of Device
CEILING LIFT
Manufacturer (Section D)
SPAN-AMERICA MEDICAL SYSTEMS
70 commerce center
greenville SC 29615
Manufacturer (Section G)
SAVARIA CONCORD LIFTS, INC.
1625 boul industrial
magog, quebec QC J1 X 5B
CA   QC J1X 5B3
Manufacturer Contact
erika ramsbottom
1625 boul industrial
magog, quebec, SC QC J1-X 5B
CA   QC J1X 5B3
8646786959
MDR Report Key14113617
MDR Text Key289293699
Report Number1041130-2022-00001
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberM929201
Device Catalogue NumberM929201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2022
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age56 YR
Patient SexFemale
Patient Weight118 KG
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