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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Display or Visual Feedback Problem (1184)
Patient Problems High Blood Pressure/ Hypertension (1908); No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) was dispatched to evaluate the iabp and was able to reproduce the reported issue. The stm adjusted the regulator to resolve the issue. All calibration, functional and safety tests were performed to meet factory specifications and the iabp was returned to the customer and cleared for clinical service.
 
Event Description
It was reported that during an inspection performed by the customer, the cardiosave intra-aortic balloon pump (iabp) generated error code #14 and was unable to start. An attempt was made to turn the iabp off and on, but the iabp did not start and took time to rise in pressure. There was no patient involvement and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key8087080
MDR Text Key127862529
Report Number2249723-2018-02007
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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