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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRATED MEASUREMENT SYSTEMS HOYER SCALE; PATIENT LIFT
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INTEGRATED MEASUREMENT SYSTEMS HOYER SCALE; PATIENT LIFT Back to Search Results
Model Number HOY-ADV-SCALE
Device Problem Material Integrity Problem (2978)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 10/27/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported to the manufacturer by the end user, per the end user, nurse and cna were transferring resident from wheelchair to bed using hoyer lift.The steel rod coming from the scale to the hoyer lift broke in half while resident was in mid-air and resident fell straight down landing on hoyer legs.The resident was transported to the local er for evaluation and sustained a vertebral fracture t11, l1/l2 transverse process fx and t9-l2 fusion.Complaint# (b)(4) and ra# (b)(4) were entered into our system to have the lift returned to joerns for investigation.As of this writing, the lift has not been returned.
 
Manufacturer Narrative
Changed to integrated measurement systems.
 
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Brand Name
HOYER SCALE
Type of Device
PATIENT LIFT
Manufacturer (Section D)
INTEGRATED MEASUREMENT SYSTEMS
1104 heinz drive, unit b
east dundee IL 60118
MDR Report Key9306549
MDR Text Key166153054
Report Number3009402404-2019-00077
Device Sequence Number1
Product Code FSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberHOY-ADV-SCALE
Device Catalogue NumberHOY-ADV-SCALE
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Weight119
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