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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC HOYER PRESENCE CRANE LIFT; PATIENT ELECTRIC LIFT
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APEX HEALTHCARE MFG INC HOYER PRESENCE CRANE LIFT; PATIENT ELECTRIC LIFT Back to Search Results
Model Number HOY-PRESENCE
Device Problems Inadequate or Insufficient Training (1643); Device Handling Problem (3265)
Patient Problems Fall (1848); Hematoma (1884)
Event Date 02/01/2014
Event Type  Injury  
Event Description
It was reported to the manufacturer by the facility ((b)(6)), per the facility, the resident was in the air being moved away from the bed.The resident suddenly fell to the floor.It was discovered that one of the sling straps was not connected.The resident was transported via 911 to the emergency room for evaluation.The resident has a right subdural hematoma.(b)(4), dir of business development, pt handling marketing, for joerns visited the facility on (b)(4) 2014 to inspect the lift and sling.The lift and sling are in good condition.(b)(4) was entered into our system.
 
Manufacturer Narrative
Joerns sending the report to the manufacturer.
 
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Brand Name
HOYER PRESENCE CRANE LIFT
Type of Device
PATIENT ELECTRIC LIFT
Manufacturer (Section D)
APEX HEALTHCARE MFG INC
min hsiun, chi yi
TW 
Manufacturer Contact
felicia banks
2100 design road
arlington, TX 76014
8008260270
MDR Report Key3731377
MDR Text Key4273913
Report Number3009402404-2014-00009
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 03/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberHOY-PRESENCE
Device Catalogue NumberHOY-PRESENCE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/24/2014
Distributor Facility Aware Date02/01/2014
Device Age33 MO
Event Location Nursing Home
Date Report to Manufacturer03/24/2014
Date Manufacturer Received02/27/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2011
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 Weight70
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