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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIP NON AC-POWERED PATIENT LIFT; 880.5510

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INVACARE REHABILITATION EQUIP NON AC-POWERED PATIENT LIFT; 880.5510 Back to Search Results
Model Number RPL600-1
Device Problem Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2014
Event Type  malfunction  
Event Description
Facility stated they have slings that are ripping at the fabric at the green edging, then the sling is ripping along the seam.
 
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Brand Name
NON AC-POWERED PATIENT LIFT
Type of Device
880.5510
Manufacturer (Section D)
INVACARE REHABILITATION EQUIP
no.435 xieyu street
suzhou industrial park
jiangsu, p.rc. 2150 26
CH  215026
Manufacturer (Section G)
INVACARE REHABILITATION EQUIP
no.435 xieyu street
suzhou industrial park
jiangsu, p.rc. 2150 26
CH   215026
Manufacturer Contact
karen loughren
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4039638
MDR Text Key4906942
Report Number3008262382-2014-00756
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 Distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 07/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberRPL600-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/28/2014
Initial Date FDA Received08/27/2014
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) Other;
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