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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET DATASCOPE CORP. SYSTEM, BALLOON, INTRA-AORTIC

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MAQUET DATASCOPE CORP. SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number 13665749
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2016
Event Type  malfunction  
Event Description
When starting pump, error message came up on screen "unable to pump". Attempted three times and received the same message. The pump was changed out and then worked properly.
 
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Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
MAQUET DATASCOPE CORP.
15 law dr
fairfield NJ 07004
MDR Report Key6043704
MDR Text Key57971200
Report Number6043704
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number13665749
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/29/2016
Event Location Hospital
Date Report to Manufacturer09/29/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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