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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 10/22/2018
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.To address the display malfunction, the stm replaced the top display lcd assembly and related labels.The stm also installed the missing compressor temperature probe and was able to verify that the compressor output test did show a compressor temperature.The vacuum regulator was reading -310mmhg, upon initial testing.Despite being calibrated to -295mmhg, the the vacuum regulator drifted back to -310+ mmhg.The stm replaced the vacuum regulator.The vacuum regulator successfully calibrated and remained permanent.The stm identified various instances of fault code 58 and readings below ambient temperature but did not observe anything faulty or potential faulty.The stm then completed the pm and peformed all functional and safety tests per factory specifications and the iabp was returned to customer and cleared for clinical use.The full name of the initial reporter listed is (b)(6) who is a getinge employee whose contact details differ from that of the event site.Please refer to the following email as contact information for the initial reporter: (b)(6).
 
Event Description
It was reported that during a preventive maintenance (pm) performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) had a horizontal line displayed on the top lcd screen.The stm also identified no compressor temperature reading as part of pm compressor output test; and the compressor temperature probe was missing.There was no patient involved; thus no adverse event reported.
 
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Brand Name
CARDIOSAVE HYBRID TYPE B PLUG
Type of Device
SYSTEM, 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 Key8080853
MDR Text Key127567304
Report Number2249723-2018-01983
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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