MAUDE Adverse Event Report: INVACARE REHABILITATION EQUIPMENT CO. HYDRAULIC LIFT W/ADJ BASE 9153629360; LIFT, PATIENT, NON-AC-POWERED

Model Number 9805

Device Problems Bent (1059); Collapse (1099)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Should additional information become available, a supplemental record will be filed.User¿s manual review- (1024492 rev.E, page 12) regular maintenance of patient lifts and accessories is necessary to assure proper operation.

Event Description

Reporter alleges his father is (b)(6) years of age and his mother has memory loss and the father was lifting the mother from the bed to bath her and the leg twisted underneath and the mother fell.Reporter states the mother is bruised on right leg and buttocks, mother weighs 220 pounds.No medical attention sought.Reporter states the lift has been in a room and used periodically and reporter is not aware when the unit has been serviced.Reporter states the rear caster broke and gave way to the weight and collapsed and the frame is bent.

• Brand Name: HYDRAULIC LIFT W/ADJ BASE 9153629360
• 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: 5757873
• MDR Text Key: 48466603
• Report Number: 3008262382-2016-00564
• 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: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/23/2016

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: 9805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 100