MAUDE Adverse Event Report: INVACARE TAYLOR STREET RELIANT 600 HD LOW BASE LIFT 9153640382; LIFT, PATIENT, NON-AC-POWERED

Model Number RPL600-1

Device Problems Bent (1059); Break (1069); Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/01/2016

Event Type  Injury  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.User¿s manual review (b)(4) warning - 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.Regular maintenance of patient lifts and accessories is necessary to assure proper operation.

Event Description

Reporter stated that she had a patient up in the air and the bolt that holds the hanger on broke and bent.The patient fell and she hit the floor.Reporter stated she fell on her right hip.The ambulance is there right now taking her to the hospital.Update from consumer affairs: reporter stated end user returned to facility with a broken pelvis.Reporter stated the bolt that holds the hanger bar on came loose and fell out causing the hanger bar and patient to fall.No further information provided at this time.

Manufacturer Narrative

Product was returned for evaluation.The return fields in oracle state: patient transport.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the swivel bar bolt breaking or bending.However, it was observed that the attachment brackets were bent and the swivel bar was unable to attach to the lift.Complaint was not confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.User¿s manual review (1078987 rev.L, page 10) warning - 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.Regular maintenance of patient lifts and accessories is necessary to assure proper operation.

Event Description

Product was returned for evaluation.The return fields in oracle state: patient transport.Other, hold for detailed evaluation.Product received expanded evaluation.The expanded evaluation report states: utilizing existing complaint information, actual observations, and functional testing of the returned product in its "as received" condition, the complaint was not confirmed for the swivel bar bolt breaking or bending.However, it was observed that the attachment brackets were bent and the swivel bar was unable to attach to the lift.Reporter stated that she had a patient up in the air and the bolt that holds the hanger on broke and bent.The patient fell and she hit the floor.Reporter stated she fell on her right hip.The ambulance is there right now taking her to the hospital.Update from consumer affairs: reporter stated end user returned to facility with a broken pelvis.Reporter stated the bolt that holds the hanger bar on came loose and fell out causing the hanger bar and patient to fall.No further information provided at this time.

• Brand Name: RELIANT 600 HD LOW BASE LIFT 9153640382
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5549850
• MDR Text Key: 41951452
• Report Number: 1525712-2016-00948
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RPL600-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2016
• 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 Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 77