MAUDE Adverse Event Report: PRISM MEDICAL CARRY BAR; NONE

Model Number 360755

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

Patient Problem Fall (1848)

Event Date 11/19/2013

Event Type  malfunction  

Event Description

During a patient transfer of a female patient ((b)(6), the pin in the carry bar broke through the plastic insert in a 360755 carry bar resulting in the patient dropping 12" to the bed.She had minor back injuries and was seen by the facility doctor.

Manufacturer Narrative

Our investigation of the received failed carry bar showed that the pin had been riding slanted after the plastic insert cracked.The pin and metal insert showed dents.Based on our investigation it would appear that the root cause is that the carry bar was used in a damaged state for a long period of time.The plastic insert was cracked and allowed the pin to shift slightly inside the channel until one edge of the pin pushed through the plastic insert and opening in the top plate.The warranty of the carry bar is 1 year and we would have replaced the product through our product return process if contacted regarding the issue.We will replace the failed carry bar with our 360760 easy swivel model which features a metal insert since the 360755 model is no longer being manufactured.We will remind the facility to inspect the products for damage per recommendations in the owner's manual.

• Brand Name: CARRY BAR
• Type of Device: NONE
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: kara lyle ; 87 sharer road; vaughan, on L4L 8-Z3 ; 8509003X23
• MDR Report Key: 3830100
• MDR Text Key: 4450304
• Report Number: 3007802293-2014-00010
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• 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: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 360755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 57