MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. OVERHEAD COUNTERPOISE SYSTEM

Model Number 59880288

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

Bayer product analysis reviewed the photographs and confirmed the subject vsa and upper flexure assembly disengaged due to a failure of the bond joint between the two components.The cause of the reported problem was a failure of the bond joint between the vsa and the upper flexure.This allowed the vsa to disengage from the system.Bayer service records indicate that the ocs ii (sn (b)(4)) was installed at this location in (b)(6) 2006.In addition, the site did not have a current service agreement with bayer at the time of the alleged incident.The last documented preventive maintenance (pm) by a certified bayer field service representative was in 2008.In-house biomedical staff at the site repaired the system and thus the attempts to receive parts related to this alleged incident were not possible.

Event Description

Bayer service reported the following: the vertical support arm (vsa) of the overhead counterpoise system (ocs) disconnected from the upper flexure assembly of the ocs.No injury or adverse event was reported.

• Brand Name: OVERHEAD COUNTERPOISE SYSTEM
• Type of Device: OVERHEAD COUNTERPOISE SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; 1 bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 7179965
• MDR Text Key: 97741965
• Report Number: 2520313-2018-00013
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: 59880288
• Device Catalogue Number: OCS II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2006
• 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