UNO

MDR report key: 1946016 · Received December 17, 2010

Report

Report Number: 8030916-2010-00078
Event Type: Malfunction
Date Received: December 17, 2010
Date of Event: December 3, 2009
Report Date: December 3, 2009
Manufacturer: LIKO AB
Product Code: FSA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.

Description of Event or Problem · 1

FACILITY REPORTED THAT A PATIENT WAS BEING TRANSFERRED FROM A BED TO A CHAIR BY TWO CNA'S. WHILE BACKING UP, THE SLING SLIPPED OFF OF THE SLING BAR. NO SAFETY LATCHES WERE PRESENT. THE PATIENT FELL TO THE FLOOR AND LANDED ON HEAD AND RIGHT SHOULDER. PATIENT WAS TAKEN TO THE HOSPITAL TO BE EXAMINED. PATIENT SUFFERED BUMP TO THE HEAD. THE LIFT IS STILL IN SERVICE AND IS FUNCTIONING PROPERLY. CNA'S HAVE BEEN RETRAINED ON PROPER USE OF PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNO	NON-AC POWERED PATIENT LIFT	FSA	LIKO AB	UNO 100EM

Patients

Seq	Age	Sex	Outcome	Treatment
1