MAUDE Adverse Event Report: APEX HEALTH CARE MFG.,INC DIRECT SUPPLY; LIFT, PATIENT LIFT, AC-POWERED,

Model Number DS-13242

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Tissue Damage (2104)

Event Date 01/26/2017

Event Type  Injury  

Manufacturer Narrative

Based on the description and photos provided from (b)(4), we judge this incident was caused by improper use of caregivers.The caregivers might not put strap of the sling into the hook fully and properly, or just hang the strap on the top of the hook instead into the hook.This is the only possibility the sling might slide off the hook.We carefully inspect the hook design, as long as the strap is fully loaded in hook, even there is a small gap between the clip and hook, the sling might only move in toward to patient lift due to the gravity.The sling won't slide out the hook.Also, the sling was not ripped and lift hook were not broken, which proven our judgement.By the way,the caregiver should always look at the resident carefully when raising up the lift, if the caregiver did the above behavior,the accident might not happen.

Event Description

We received form 2500a report#(b)(4) on feb 27 2017.This event was described by our customer ((b)(4)) of usa as below: the patient was being lowered from patient lift by two certified nursing assistants, when allegedly the left side sling loop slipped out of the lift hook causing her to fall 2-3 feet to the floor.The patient was taken to the er showed a fractured right femur.However, it lead to an amputation since the patient was already battling an infection in the same leg.(b)(6) from (b)(6) confirmed the sling was not ripped and the lift hooks were not broken.Acoording to engineers at (b)(6), they discovered that the hook clip was not functioning properly therefore the sling loop may have slipped out.Drive has requested the patient lift for internal evaluation but was declined because (b)(6) does not want to release the item.

• Brand Name: DIRECT SUPPLY
• Type of Device: LIFT, PATIENT LIFT, AC-POWERED,
• Manufacturer (Section D): APEX HEALTH CARE MFG.,INC; no. 6. industrial 2nd rd.; tao chiao industrial park; chiayi hsien, 62152 ; TW 62152
• Manufacturer Contact: carol liao ; no. 6 industrial 2nd rd; tao chiao industrial park; chia yi hsien, 62152 ; TW 62152
• MDR Report Key: 6438408
• MDR Text Key: 70977169
• Report Number: 3010605276-2017-00001
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/27/2017

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: Nursing Assistant
• Device Model Number: DS-13242
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2017
• Initial Date FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 91