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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE E/F PLG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-55
Device Problem Temperature Problem (3022)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted when additional information is provided.(b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) overheated.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit by performing a compressor test and observed a power drop.The fse replaced the scroll compressor, muffler, and temperature sensor.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.It is expected that the suspected faulty scroll compressor will be returned to getinge's national repair center (nrc) for failure analysis; a supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) overheated.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
 
Event Description
It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) overheated and stopped patient therapy.It was also reported that the unit correctly alarmed for the reported malfunction.Further, it was reported that another maquet iabp unit was used to continue therapy.No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
Analysis of production: (3331/102) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/102) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/102) the overall 24 month product complaint trend data for the period mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.A cr/capa/scar/ncmr review was conducted for the two year period mar 2019 through feb 2021.
 
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Brand Name
CARDIOSAVE HYBRID TYPE E/F PLG
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11382814
MDR Text Key233752555
Report Number2249723-2021-00454
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108414
UDI-Public10607567108414
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-55
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
INTRA-AORTIC BALLOON.
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