MAUDE Adverse Event Report: MEDCARE PRODUCTS CEILING LIFT 625 (LIFTS UP TO 625 LBS.)

Model Number 323120

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

Event Type  malfunction  

Event Description

The nurse used the hand remote to lower the sling of the ceiling lift and then to raise the patient from the bed.When she tried to lower the patient to the wheelchair the lift did not move.At that point she pulled the emergency cord to lower the patient and it failed to do so.Later investigation indicated that the lift had been compromised previously in the way it was operated.What can happen is that when the lift is lowered all the way down the motor will reverse and then spool backwards.The hook mechanism spools up into the motor housing.Then the lift can get stuck in the up position.It was found that the ceiling lift was operating according to instructions.However, the possibility of the spooling backwards creates a high potential for patient harm.This is the second time there has been an incident with the ceiling lift.The point of reporting is to make others aware of the possibility of a similar event.This could be life threatening or create an incident.

• Brand Name: CEILING LIFT 625 (LIFTS UP TO 625 LBS.)
• Type of Device: CEILING LIFT
• Manufacturer (Section D): MEDCARE PRODUCTS; 151 east cliff road; burnsville MN 55337
• MDR Report Key: 6649533
• MDR Text Key: 77831606
• Report Number: 6649533
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2017,06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 323120
• Device Catalogue Number: 323120
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2017
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES