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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNRISE MEDICAL HOYER
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SUNRISE MEDICAL HOYER Back to Search Results
Model Number 400-3404
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893)
Event Date 08/28/2017
Event Type  Death  
Event Description
Hemodialysis patient completed dialysis treatment at approximately 11:20 am.Patient's personal sling pad had remained under patient throughout dialysis treatment in the dialysis recliner chair.Hoyer lift device was utilized to transfer patient from dialysis chair to patient's personal wheelchair.During lift transfer of patient to personal wheelchair, patient slipped out of sling pad and fell to the floor hitting her head.Patient had laceration to right eyebrow and was bleeding.Patient was slow to respond."911" was called.Patient was transferred to hospital and admitted.Patient expired (b)(6) 2017.
 
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Brand Name
HOYER
Type of Device
HOYER
Manufacturer (Section D)
SUNRISE MEDICAL
longmont CO 80503
MDR Report Key6893876
MDR Text Key87446388
Report Number6893876
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 User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number400-3404
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/12/2017
Distributor Facility Aware Date08/28/2017
Device Age6 YR
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/12/2017
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;
Patient Age63 YR
Patient Weight48
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