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

Model Number 9805P

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The dealer stated that the lift was being used at home on a single patient with one caregiver.He stated that the lift had not been used at another residence prior to being delivered to this patient.He stated that the caregiver reported the bent leg after the first time the lift was used.The caregiver claims that nothing was pushed down on the legs of the lift.The dealer had no further details on how the lift was being used by the caregiver.The patient discontinued use of the lift and ordered a replacement through a different company.The dealer stated that he went to the patient's house to retrieve the damaged lift and confirmed that the leg was bent and the caster was about 3 inches off the ground.A photograph was provided of the base of the lift which shows that the front left caster is not making contact with the ground.At this time, the underlying cause of the bent leg cannot be determined, and a product malfunction cannot be confirmed.An rma was issued for the return of the base of the lift to invacare for evaluation; however, it has not yet been received.Should additional information become available, a supplemental record will be filed.

Event Description

The dealer stated that the patient's caregiver alleged that she transferred the patient from a wheelchair to a bed and then afterwards she noticed that the legs of the lift were bent.

• 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 21521 ; CH 21521
• Manufacturer (Section G): INVACARE REHABILITATION EQUIPMENT CO.; no.5 weixi road, sip; suzhou, jiangsu 21521 ; CH 21521
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 6676942
• MDR Text Key: 78694287
• Report Number: 3008262382-2017-00012
• 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: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 9805P
• Device Catalogue Number: 9805P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 82