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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800
Device Problems No Display/Image (1183); Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/10/2019
Event Type  malfunction  
Event Description
Intra-aortic balloon pump made a high pitch noise then the screen went black and completely stopped working.It was still powered on, but not working.The rn turned off the machine then turned it back on and it resumed working.Rn called maquet for support.They recommended taking machine out of service and submit a work request, which was done.
 
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Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key10133153
MDR Text Key194493562
Report Number10133153
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/26/2020,09/16/2019
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 Number0998-00-0800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2020
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer06/09/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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