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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 Problems Failure to Charge (1085); Off-Label Use (1494)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Manufacturer Narrative
The failure was observed by the end user, not charging batteries after an on transport operation, the customer performed the battery run test and batteries depleted. As per the biomed once plugged in to charge, the battery cycle would start, then stop. The getinge field service engineer (fse) performed the battery charging sequence and observed bay 1 battery charging and stopping, he removed the bay battery and charging sequence started on bay 2 battery. The issue was isolated to defective battery in bay 1 s/n(b)(4)). The customer supplied a battery from spare pump and installed and tested. The battery charging sequence operated to specifications. Unit passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) was having a battery charging issue. 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.
 
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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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12062532
MDR Text Key265587272
Report Number2249723-2021-01344
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 Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/13/2022
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
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/21/2017
Is the Device Single Use? No
Type of Device Usage Reuse

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