MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/LOW BASE-PLUS 9153633521; LIFT, PATIENT, NON-AC-POWERED

Model Number 9805P

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available a supplemental record will be filed.

Event Description

Dealer advised base bent.

Manufacturer Narrative

Additional/updated information was added to reflect the device being returned to the manufacturer for evaluation.The result of the evaluation was that the front end of the left leg was bent upward, which confirmed the original complaint issue.However, the underlying cause could not be determined.

Event Description

Dealer advised base bent.

• Brand Name: HYDRAULIC LIFT W/LOW BASE-PLUS 9153633521
• 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 Key: 5359642
• MDR Text Key: 35979621
• Report Number: 3008262382-2016-00026
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

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 Number: 9805P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/06/2016
• 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