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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAVARIA CONCORD LIFTS INC. MONARCH FL CEILING LIFT
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SAVARIA CONCORD LIFTS INC. MONARCH FL 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 her 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.
 
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 her 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
This follow-up report is being submitted to correct 5-day that was checked in error on the initial report.Instead, only initial box should have been checked.
 
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 fall and preexisting condition.The dealer suspected that the spreader bar is being taken in the shower and never disconnected based on the substantial soap residue/rust at connection point.The investigation is ongoing.
 
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Brand Name
MONARCH FL CEILING LIFT
Type of Device
CEILING LIFT
Manufacturer (Section D)
SAVARIA CONCORD LIFTS INC.
2 walker drive
brampton, ontario L6T 5 A1
CA  L6T 5 A1
Manufacturer (Section G)
SPAN-AMERICA MEDICAL SYSTEMS
70 commerce center
greenville SC 29615
Manufacturer Contact
bill richardson
2 walker drive
brampton, ontario L6T 5-A1
CA   L6T 5A1
MDR Report Key13870298
MDR Text Key287785715
Report Number3005753836-2022-00001
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,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 09/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
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
Device Lot Number2019-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2022
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age70 YR
Patient SexFemale
Patient Weight200 KG
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