FDA Adverse Event Malfunction Summary report: N

COMBI SLING

MDR report key: 2926498 · Received January 18, 2013

Report

Report Number: 2926498
Event Type: Malfunction
Date Received: January 18, 2013
Date of Event: January 13, 2013
Report Date: January 18, 2013
Manufacturer: TOLLOS, INC.
Product Code: FSA
Product Problem: Yes
Report Source: User Facility report
Reporter Location: DE, US

Narratives

Description of Event or Problem · 1

STAFF MEMBERS WERE ASSISTING THE PATIENT INTO THE WHEELCHAIR. THE NURSE USED THE SIDE HANDLES TO HELP POSITION THE PATIENT IN THE WHEELCHAIR. THE SIDE HANDLE TORE AWAY FROM THE SLING FABRIC. THE NURSE REMOVED THE SLING FROM USE AND PLACED IT IN A PLASTIC BAG IN THE NURSE MANAGER'S OFFICE. THE SLING IS LOT #1631210BD DISTRIBUTED BY (B)(6) MEDICAL.A SCHEDULE HAS BEEN MADE FOR THE VENDOR TO INSERVICE THE REHAB DEPARTMENT. A NOTICE HAS BEEN PLACED IN THE STAFF LOUNGE TO ALERT STAFF TO NOT USE THE SIDE HANDLES TO PULL OR POSITION THE PATIENT. PT'S WEIGHT (B)(6) KG. USED LARGE GREEN SLING -T015CXF LARGE 175-249 LBS GREEN 600 LBS 43" 43".

Description of Event or Problem · 1

STAFF MEMBERS WERE ASSISTING THE PATIENT INTO THE WHEELCHAIR. THE NURSE USED THE SIDE HANDLES TO HELP POSITION THE PATIENT IN THE WHEELCHAIR. THE SIDE HANDLE TORE AWAY FROM THE SLING FABRIC. THE NURSE REMOVED THE SLING FROM USE AND PLACED IT IN A PLASTIC BAG IN THE NURSE MANAGER'S OFFICE. THE SLING IS LOT #1631210BD DISTRIBUTED BY T.H.E. MEDICAL.A SCHEDULE HAS BEEN MADE FOR THE VENDOR TO INSERVICE THE REHAB DEPARTMENT. A NOTICE HAS BEEN PLACED IN THE STAFF LOUNGE TO ALERT STAFF TO NOT USE THE SIDE HANDLES TO PULL OR POSITION THE PATIENT. PT'S WEIGHT 68.5 KG. USED LARGE GREEN SLING -T015CXF LARGE 175-249 LBS GREEN 600 LBS 43" 43".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
27792	COMBI SLING	PATIENT LIFT, SLING	FSA	TOLLOS, INC.	*	1631210BD

Patients

Seq	Age	Sex	Outcome	Treatment
1	*