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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED
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INVACARE REHABILITATION EQUIPMENT CO. POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI; WHEELCHAIR, POWERED Back to Search Results
Model Number M41SRB
Device Problems Loose or Intermittent Connection (1371); Component Missing (2306); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Dealer is stating that the top left under the seat has no threaded hole to accept the screw that attaches to the mounting bracket.Also the dealer is stating that 2 screw and washers are now missing from the seat.Seat was very loose and wobbly end user wasn't using the chair.Dealer did not notice that there was no thread when the chair was put together back in (b)(6) 2014.
 
Manufacturer Narrative
Should additional information become available a supplemental record will be filed.
 
Manufacturer Narrative
(b)(4).Device evaluation received 6.22.2015.Conclusion: seat: although the seat pivot is not loose/there are two seat bolts missing/and one of them also has the t nut missing; washers and screws: dealer returned new unused parts.
 
Event Description
Dealer is stating that the top left under the seat has no threaded hole to accept the screw that attaches to the mounting bracket.Also the dealer is stating that 2 screw and washers are now missing from the seat.Seat was very loose and wobbly end user wasn't using the chair.Dealer did not notice that there was no thread when the chair was put together back in (b)(4) 2014.
 
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Brand Name
POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI
Type of Device
WHEELCHAIR, 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 Key4858462
MDR Text Key19307816
Report Number3008262382-2015-01369
Device Sequence Number1
Product Code ITI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor,distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 06/22/2015
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 NumberM41SRB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/27/2015
Initial Date FDA Received06/22/2015
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
Patient Outcome(s) Other;
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