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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The lift arm bent while trying to get the end user off of the ground.

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: visual inspection- the boom bar was bent near the model number and boom lugs.Functional observation- because the boom bar was the only component returned, no functional testing could be performed.Conclusions- utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was confirmed for the boom bar being bent.Complaint was confirmed.The underlying cause could not be determined after reviewing the documentation in this investigation.

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: visual inspection- the boom bar was bent near the model number and boom lugs.Functional observation- because the boom bar was the only component returned, no functional testing could be performed.Conclusions- utilizing existing complaint information and actual observations of the returned product in its "as received" condition, the complaint was confirmed for the boom bar being bent.The lift arm bent while trying to get the end user off of the ground.

• 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 Key: 5430273
• MDR Text Key: 38550002
• Report Number: 3008262382-2016-00109
• 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,Followup
• Report Date: 03/18/2016

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: 03/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2016
• Initial Date FDA Received: 02/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• 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 Weight: 122