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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679; LIFT, PATIENT, NON-AC-POWERED

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INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number 9805P
Device Problems Bent (1059); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Mdr is being submitted as a result of a retrospective complaint review.The underlying cause is identified as the left leg is bent upward, and the left front caster is off the ground.
 
Event Description
Per provider the customer stated the front left leg is bent and the caster is off the ground.
 
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Brand Name
HYDRAULIC LIFT W/ADJ BASE BEIGE POWDERCOAT 9153644679
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 Key5633364
MDR Text Key44887172
Report Number3008262382-2016-00281
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 05/15/2014
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 Number9805P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/19/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/15/2014
Initial Date FDA Received05/05/2016
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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