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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Failure to Charge (1085)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: (10) a getinge field service engineer (fse) performed battery run test and and depleted batteries. As per biomed once plugged in to charge battery cycle would start then stop. The fse performed battery charging sequence and observed bay 1 battery charging and stopping. The fse removed bay battery and and charging sequence started on bay 2 battery. The fse then isolated failure to defective battery in bay 1. The customer supplied battery from spare pump and installed and tested. Battery charging sequence operations to meet specifications. Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
 
Event Description
It was reported that during use the cardiosave intra-aortic balloon pump (iabp) the battery charging sequence fails to resume after the unit was re-connected. There was no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12060112
MDR Text Key265585042
Report Number2249723-2021-01341
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 08/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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