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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL ATS 3000 NETHERLANDS
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ZIMMER SURGICAL ATS 3000 NETHERLANDS Back to Search Results
Catalog Number 60-3000-301-12
Device Problem Deflation Problem (1149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2014
Event Type  malfunction  
Event Description
It was initially reported that the zimmer ats 3000 would deflate during surgery and after disconnecting the cuffs, the ats would inflate.Additional clinical info determined that there was pt involvement associated with the report and there was leakage of blood due to the deflation of the cuff.It was clarified that the amount of blood loss that was observed during the reported event was less than 100cc.There was a delay of around 15 minutes to the surgery and no alternate device was retrieved for use during the procedure.No further clinical info is indicated.
 
Manufacturer Narrative
The device was not returned to the manufacturer at the time of this report.A follow up medwatch will be submitted once the device has been returned and the investigation is complete.
 
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Brand Name
ATS 3000 NETHERLANDS
Type of Device
ATS 3000 NETHERLANDS
Manufacturer (Section D)
ZIMMER SURGICAL
200 west ohio ave.
dover OH 44622
Manufacturer Contact
kathleen smith
200 west ohio ave.
dover, OH 44622
3303438801
MDR Report Key4015997
MDR Text Key18291366
Report Number1526350-2014-00397
Device Sequence Number1
Product Code KCY
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number60-3000-301-12
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/23/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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