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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. RELIANT 600 HD POWER LOW BASE LIFT 9153646721; LIFT, PATIENT, NON-AC-POWERED

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INVACARE REHABILITATION EQUIPMENT CO. RELIANT 600 HD POWER LOW BASE LIFT 9153646721; LIFT, PATIENT, NON-AC-POWERED Back to Search Results
Model Number RPL600-2
Device Problem Material Separation (1562)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 07/05/2016
Event Type  Injury  
Manufacturer Narrative
The user¿s manual warns that when transferring the patient the mast pivot under the rubber boot must be tight to ensure safe use of the patient lift.Bolt must be checked at least every six months in conjunction with periodic maintenance.Maintenance must be performed only by qualified personnel.After the first twelve months of operation, inspect the hanger bar and the eye of the boom (to which it attaches) for wear.If the metal is worn, the parts must be replaced.Make this inspection every six months thereafter.Do not over tighten mounting hardware.This will damage mounting brackets.Regular maintenance of patient lifts and accessories is necessary to assure proper operation.It is unknown whether the maintenance reported was performed by a qualified personnel.Multiple attempts have been made for additional information from the facility regarding the alleged event and maintenance of the lift.Messages have also been left requesting photographs and the return of the lift for inspection.Return material authorization has not been issued for the return of this device for investigation; return not anticipated at this time.However, the dealer stated they will also attempt to contact the facility to set up a return for inspection.Patient information not available, as the facility declined to provide additional information for the patient.If additional information should become available, this record will be updated accordingly.
 
Event Description
Consumer states that a patient was in the lift and the swivel bar separated from the boom causing the patient to fall on the ground.Consumer states that the patient that fell broke their femur bone.Consumer states that they do regular maintenance in tightening the swivel bar and boom once a month, and clean the lifts once a week.Consumer states the last tightening on this unit was (b)(6) 2016.Consumer declined to provide patient information at this time.No additional information provided.
 
Manufacturer Narrative
Additional/updated information was added to reflect the lift being returned to the manufacturer for evaluation, however subsequent testing could not verify the complaint.Per the expanded evaluation report, the failure of the hangar bar shoulder bolt coming out was not able to be duplicated.While there was damage to the u-bracket of the boom which did not allow the shoulder bolt locknut to completely tighten as intended, the shoulder bolt and locknut for the hangar bar remained tightly attached while the lift was raised/lowered and manipulated both with and without a load attached.If the shoulder bolt and locknut are tightened correctly, it is not possible for the bolt to back out.Even if the locknut was hypothetically missing, a fully inserted shoulder bolt would not slide out easily if there is a patient lifted because of the side load applied to the bolt when a patient is supported.The bending damage to the u-bracket that was observed suggests that the nut was not present prior to the patient being lifted.This type of damage would occur if the bolt had been inserted from the side of the bracket which was eventually bent, and was not subsequently secured with the locknut.Without the nut, the bolt would have been apt to move, or partially back out to the point where the threaded end of the bolt was only minimally supported by the opposite side of the u-bracket, while the lift was being maneuvered into position.Then, once the patient was lifted, the process of moving/positioning the suspended patient would have resulted in a loss of support from one side of the u-bracket; thus, causing the entire patient load to cantilever on the opposite side of the u-bracket, leading to the bending damage observed.Therefore, the incident is likely the result of poor maintenance at the facility because the lift was used without the locknut securing the shoulder bolt in the u-bracket.The following fields were updated accordingly.
 
Event Description
Consumer states that a patient was in the lift and the swivel bar separated from the boom causing the patient to fall on the ground.Consumer states that the patient that fell broke their femur bone.Consumer states that they do regular maintenance in tightening the swivel bar and boom once a month, and clean the lifts once a week.Consumer states the last tightening on this unit was (b)(6) 2016.Consumer declined to provide patient information at this time.No additional information provided.
 
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Brand Name
RELIANT 600 HD POWER LOW BASE LIFT 9153646721
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
jason fiest
one invacare way
elyria, OH 44035
8003336900
MDR Report Key5825471
MDR Text Key50523051
Report Number3008262382-2016-00600
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 user facility
Reporter Occupation Other Caregivers
Remedial Action Replace
Type of Report Initial,Followup
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberRPL600-2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/26/2016
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
Patient Outcome(s) Hospitalization;
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