MAUDE Adverse Event Report: PRISM MEDICAL CEILING MOUNTED PATIENT LIFT

Model Number C-625

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Patient Involvement (2645)

Event Date 09/11/2017

Event Type  malfunction  

Event Description

Nurses on an inpatient unit discovered a non-working lift prior to admitting a new patient.Biomedical engineering was called in and a biomedical equipment support specialist couldn't diagnose the issue on the unit in the room.The tech could tell that the led display for the battery charge indicator was busted by the metal bracket due to the lift being up all the way and noticed that the hand control directional buttons were reversed.He called the vendor who explained the bracket issue, and the hand control issue and reported that it wasn't covered under the warranty and was considered a user error.The vendor explained that when the user goes to raise the patient lift all the way up, the metal bracket on top of the patient lift bar crushes the battery charge indicator led display, and will also cause an additional "reverse spool" issue.When the internal spool reaches its maximum endpoint upon raising it all the way up, the belt starts spooling out in the reverse direction.This causes the hand control, up and down, button functions to be reversed.The unit has yet to be repaired, parts have not been ordered yet.In addition to those issues, the batteries are very difficult to replace, because you practically have to take the entire casing off to get the batteries out.

• Brand Name: CEILING MOUNTED PATIENT LIFT
• Type of Device: CEILING MOUNTED PATIENT LIFT
• Manufacturer (Section D): PRISM MEDICAL
• MDR Report Key: 6868377
• MDR Text Key: 86563724
• Report Number: MW5072154
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C-625
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1