MAUDE Adverse Event Report: NINGBO SOUTH INDUSTRIAL CO., LTD. UPLIFT SEAT ASSIST; LIFTING SEAT

Model Number MED-UL100

Device Problem Use of Device Problem (1670)

Patient Problems Death (1802); Bone Fracture(s) (1870)

Event Date 08/03/2013

Event Type  Death  

Event Description

Son showed mother uplift seat assist he had purchased.He took it out of the box and began to adjust the weight setting.He remembers looking at the box, but does not remember reading the written instructions contained inside the package.He did not see any warning not to place the device in a wheelchair.Son initially set the weight setting on the lowest setting: 80 lbs.That setting did not provide his mother (who he said weight (b)(6) at the time of the accident) with enough assistance to rise out of the chair.Therefore, he adjusted the setting to (b)(6).His mother's walker was in front of her wheelchair.The wheels on her wheelchair were locked.She gripped the handles on her wheelchair and was able to stand with the uplift seat assist on the (b)(6) weight level.Son watched his mother stand twice before she sat back down on the device and they began to talk.As they were catching up that afternoon, his mother unlocked the wheels of her wheelchair and began rolling towards the open door of her apartment.She used both her hands and her feet to move her wheelchair.After she passed behind her son, he heard her say "oh! oh!" he saw his mother had fallen in an "unnatural position", face first on the ground, with her head between her knees.She hit her head on the floor and had a "goosebump" on her head.They called 911 and she was immediately transferred to the hospital, where she was admitted.They later learned that she had a "brain bleed" and two broken legs.Mother was transported via ambulance to (b)(6) hospital, where she was diagnosed with bilateral femur fractures.She died the next day.

• Brand Name: UPLIFT SEAT ASSIST
• Type of Device: LIFTING SEAT
• Manufacturer (Section D): NINGBO SOUTH INDUSTRIAL CO., LTD.; fengcheng village, jishigang town; yinzhou, ningbo ; CH
• MDR Report Key: 4755173
• MDR Text Key: 21057288
• Report Number: 9681423-2015-00001
• Device Sequence Number: 1
• Product Code: INM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/01/2015

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: MED-UL100
• Device Catalogue Number: MED-UL100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2015
• Distributor Facility Aware Date: 04/06/2015
• Event Location: Other
• Date Report to Manufacturer: 05/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WHEEL CHAIR
• Patient Outcome(s): Death
• Patient Age: 93 YR
• Patient Weight: 48