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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. RELIANT 600 HD LOW BASE LIFT 9153640382; LIFT, PATIENT, NON-AC-POWERED
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INVACARE REHABILITATION EQUIPMENT CO. RELIANT 600 HD LOW BASE LIFT 9153640382; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number RPL600-1
Device Problem Component Falling (1105)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Should additional information become available, a supplemental record will be filed.
 
Event Description
On the afternoon of (b)(6) 2016 they were trying to raise a resident in the lift and a bolt fell out causing the lift to drop suddenly.This bolt is where the hanger bar connects to the lift.
 
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Brand Name
RELIANT 600 HD LOW BASE LIFT 9153640382
Type of Device
LIFT, PATIENT, NON-AC-POWERED
Manufacturer (Section D)
INVACARE REHABILITATION EQUIPMENT CO.
no.5 weixi road, sip
suzhou jiangsu 21512 1
CH  215121
Manufacturer (Section G)
INVACARE REHABILITATION EQUIPMENT CO.
no.5 weixi road, sip
suzhou jiangsu 21512 1
CH   215121
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5398456
MDR Text Key37093835
Report Number3008262382-2016-00087
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 01/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2016
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received01/15/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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