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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: H FINE & SONS LTD HOYER COMFORT 4-POINT SLING; PATIENT SLING
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H FINE & SONS LTD HOYER COMFORT 4-POINT SLING; PATIENT SLING Back to Search Results
Model Number NA25504
Device Problems Inadequate or Insufficient Training (1643); Device Handling Problem (3265)
Patient Problems Fall (1848); Hematoma (1884)
Event Date 01/16/2014
Event Type  Injury  
Event Description
It was reported to the manufacturer by the facility ((b)(6)), per the facility, the resident was being moved from a wheelchair to the bed via a sling attached to the lift.The two cna's said, they heard a noise and the resident fell backwards out of the sling.The resident landed on the floor on her head and back.The cna's called for a nurse.The nurse called 911 for transport to the hospital as a precaution.The resident received a ct scan and other testing.The resident had a hematoma on the front and side of the head.The resident was first at (b)(6) and then transferred to (b)(6).(b)(6) was notified that the resident was transferred to (b)(6) and that the resident was doing well.(b)(6) was then notified that the residents' death had occurred on (b)(6) 2014.The resident had dementia and ms.Her body was severely contracted and she had no body control.(b)(4), corporate accounts-clinical accounts manager for joerns, visited the facility on (b)(4) 2014 to inspect the lift and sling.His report stated "the lift in question is in good working order with no apparent issues or concerns.The sling in question was also found to be in good working order.There were no tears, rips or frays found in the sling and the clips were also found to be in good condition.The staff members who were involved in the transfer, stated that the clips were all attached prior to the transfer, but the left leg clip was not connected when the incident occurred.At the conclusion of the visit, (b)(4) provided some safety and transfer education for the staff." (b)(4) was entered into our system.
 
Manufacturer Narrative
Joerns sending this report to the manufacturer.
 
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Brand Name
HOYER COMFORT 4-POINT SLING
Type of Device
PATIENT SLING
Manufacturer (Section D)
H FINE & SONS LTD
london
UK 
Manufacturer Contact
felicia banks
2100 design rd
arlington, TX 76014
8008260270
MDR Report Key3632365
MDR Text Key16799537
Report Number3009402404-2014-00002
Device Sequence Number1
Product Code FNG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNA25504
Device Catalogue NumberNA25504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/07/2014
Distributor Facility Aware Date01/16/2014
Event Location Nursing Home
Date Report to Manufacturer02/07/2014
Date Manufacturer Received01/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age75 YR
Patient Weight76
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