MAUDE Adverse Event Report: PRISM MEDICAL C SERIES CARRY BAR- SS

Model Number 360755 REV B

Device Problems Break (1069); Inadequate Service (1564)

Patient Problem Fall (1848)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

While a male patient was being transferred from a chair to a bed, the plastic swivel insert (635090) inside the carry bar (360755 rev b) broke which caused the strap to come out of the bar.The patient fell a few inches back down into the chair and was not injured.Ron spring, a biomedical technician with erie county medical centre, investigated and observed the cause of failure was the plastic insert (b)(4) of the carry bar cracking and breaking.The lift strap was, therefore, able to pull through.

Manufacturer Narrative

The root cause of the issue is that the customer was using a damaged carry bar.As a corrective action, we have written and distributed a technical bulletin with instructions to replace any insert with a visible deformation and a reminder to inspect all visible load bearing components of the lift as per normal safe operating procedures, and to complete a detailed visual inspection of the load bearing components of the lift as part of routine preventative maintenance.The bulletin also recommends to take any carry bar with a deformed or cracked plastic insert out of service.

• Brand Name: C SERIES CARRY BAR- SS
• Type of Device: CARRY BAR
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: kara lyle ; 87 sharer road; vaughan, on L4L 8-Z3 ; 8509003X23
• MDR Report Key: 3820749
• MDR Text Key: 4402796
• Report Number: 3007802293-2014-00004
• 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: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 360755 REV B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1