MAUDE Adverse Event Report: HANDICARE USA C-SERIES; PATIENT LIFTS

Model Number C625

Device Problems Material Fragmentation (1261); Unintended Movement (3026); Device Fell (4014)

Patient Problems Bruise/Contusion (1754); Hematoma (1884); No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

While transferring a resident from bed to chair, the resident was in the sling and one cna was holding the sling handles and the other was pushing the lift from the back using the handle bar, when they were going through the door the cna holding the sling handles pulled the resident to one side so his head would not hit the door.The resident was agitated and thrashing about so they did not want him to knock himself into the door.The pulling combined with the swinging about motion that began as soon as they cleared door, likely caused the imbalance which caused the lift to turn over, dropping the resident to the floor.

Event Description

While transferring a resident, the lift imbalanced causing the lift to turn over and dropping the resident to the floor.

Event Description

The strap was sheared which dropped the carry bar and sling.The patient was not on the lift during the incident.

Manufacturer Narrative

During investigation, a crease was noticed on the strap, remnants of the strap was within the gear and the strap was cut in 2 areas.The complainant was having problems with the strap not staying straight.It was stated the user continued to turn and twist the strap to keep it straight.The lift should have taken out of service upon noticing such problem and serviced for maintenance.The lack of tension on the strap likely caused the strap to get caught in the gears.Root cause: unknown, the contributing factors may be slack introduced in the strap while lifting.Continued to use of malfunctioning lift and insufficient preventive maintenance.Corrective action: lift was replaced no further corrective action planned.

• Brand Name: C-SERIES
• Type of Device: PATIENT LIFTS
• Manufacturer (Section D): HANDICARE USA; 10888 metro court; maryland heights 63043
• MDR Report Key: 8755973
• MDR Text Key: 149927351
• Report Number: 3007802293-2019-00026
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C625
• Device Catalogue Number: 323117
• Was Device Available for Evaluation?: Yes
• Device Age: 2 YR
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Weight: 60