MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-03-28 for DIRECT SUPPLY DS-13242 manufactured by Apex Health Care Mfg.,inc.
[70977169]
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.
Patient Sequence No: 1, Text Type: N, H10
[70977170]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010605276-2017-00001 |
| MDR Report Key | 6438408 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-03-28 |
| Date of Report | 2017-03-27 |
| Date of Event | 2017-01-26 |
| Date Mfgr Received | 2017-02-27 |
| Device Manufacturer Date | 2016-07-26 |
| Date Added to Maude | 2017-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROL LIAO |
| Manufacturer Street | NO. 6 INDUSTRIAL 2ND RD TAO CHIAO INDUSTRIAL PARK |
| Manufacturer City | CHIA YI HSIEN, 62152 |
| Manufacturer Country | TW |
| Manufacturer Postal | 62152 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECT SUPPLY |
| Generic Name | LIFT, PATIENT LIFT, AC-POWERED, |
| Product Code | FNG |
| Date Received | 2017-03-28 |
| Model Number | DS-13242 |
| Operator | NURSING ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTH CARE MFG.,INC |
| Manufacturer Address | NO. 6. INDUSTRIAL 2ND RD. TAO CHIAO INDUSTRIAL PARK CHIAYI HSIEN, 62152 TW 62152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-03-28 |