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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number CARDIO SAVE HYBRID
Device Problem Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2020
Event Type  malfunction  
Event Description
Loud constant alarm heard from balloon pump. When assessing device, all waveforms were a flat line and all numbers were at zero and pump was alarming internal malfunction. When troubleshooting the device, the recommendation from the device was to turn the device off for ten seconds and to turn it back on. When this was attempted, the device did not turn back on. Patient was quickly transferred over to a new device instead. No harm to patient noted. Engineering evaluation: when tested later, the machine booted normally. Review of the error log showed two entries at the time of the incident. Screen shot of log attached. Review of the fault table showed these errors had only occurred once. Per manufacturer advice, no further corrective action is needed. Machine ran with simulator 48 hours with no further events. Manufacturer response for intra-aortic balloon pump, (brand not provided) (per site reporter). Since the error only occurred once, they said it was nothing to worry about.
 
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Brand NameCARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP.
15 law drive
fairfield NJ 07004
MDR Report Key10061111
MDR Text Key191156938
Report Number10061111
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 Other Health Care Professional
Type of Report Initial
Report Date 04/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCARDIO SAVE HYBRID
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/14/2020
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer05/15/2020
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? No
Type of Device Usage

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