MAUDE Adverse Event Report: PRISM MEDICAL F550 EZ SWIVEL CARRY BAR W/SCALE

Model Number 280520

Device Problems Device Slipped (1584); Material Integrity Problem (2978)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2015

Event Type  malfunction  

Event Description

Pt was being lowered to bed when the f550 carry bar broke.

Manufacturer Narrative

The carry bar has not been received from the end user yet to evaluate and conclude as to the cause of the separation.An update will be submitted once the part has been reviewed.User facility that reported the info to the distributor: (b)(4).

Manufacturer Narrative

Rga 19155 was assigned for the carry bar to be returned, however, the dealer had discarded the product.Due to the carry bar not being returned, we are unable to complete a thorough investigation.Root cause: undetermined correction: the carry bar has been replaced fo the customer.Corrective action: none, root cause unknown.

• Brand Name: F550 EZ SWIVEL CARRY BAR W/SCALE
• Type of Device: EZ SWIVEL CARRY BAR
• Manufacturer (Section D): PRISM MEDICAL; maryland heights MO
• Manufacturer Contact: steve kilburn ; 10888 metro ct; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 4902251
• MDR Text Key: 18635063
• Report Number: 3007802293-2015-00020
• 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: Distributor,distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 280520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/21/2015; 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1