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

Model Number 59880288

Device Problems Component Falling (1105); Disconnection (1171)

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

Event Date 11/06/2013

Event Type  malfunction  

Manufacturer Narrative

A system service check by bayer service confirmed that the vertical arm of the ocs had disengaged from the horizontal support arm.The equipment was removed and was subsequently replaced with a new ocs system.Product analysis reviewed the information and photographs that were provided.Product analysis determined that the cause of the reported issue was the failure of the glue joint between the spherical bushing and the upper flexure assembly.This allowed the vsa to disengage from the system.

Event Description

Bayer service reported the following: the vertical support arm (vsa) of the overhead counterpoise system (ocs) disconnected from the ocs and fell into a trash can.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: 7178403
• MDR Text Key: 96956301
• Report Number: 2520313-2018-00004
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2018

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: 59880288
• Device Catalogue Number: OCS II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2004
• 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