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U.S. Department of Health and Human Services

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

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BAYER MEDICAL CARE, INC. OVERHEAD COUNTERPOISE SYSTEM Back to Search Results
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.
 
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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 Key7178403
MDR Text Key96956301
Report Number2520313-2018-00004
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944983
Number of Events Reported1
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 Number59880288
Device Catalogue NumberOCS II
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2017
Initial Date FDA Received01/10/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/26/2004
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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