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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); Battery Problem (2885)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The fse determined that the power management board was the cause of the charging issue as the battery led charging indicator flashed, but then went out.To fix the issue, the fse replaced the power management board.The fse retested the unit and the charging circuit began to work properly.The fse found that one of the batteries was not taking charge and showed 0.00 capacity, even after replacing the power management board.Moreover, the fse discovered that the second battery charged, but showed a lower capacity.The fse recommended and replaced the batteries with new batteries provided by the customer, and the unit then passed the "battery run time test." although the batteries appeared to have taken full charge, both batteries had a cycle count above 30.The fse also performed a preventative maintenance (pm) service that was due at the same time of performing service repairs on the unit for the reported issue.The fse then performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.Full event site name: (b)(6).
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) batteries would not charge.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
Updated fields: b4, d5, e1(event site email), e2, e3, g3, g4, g7, h2, h10, h11.Corrected fields: h6 (patient codes).It was reported that the customer's biomed was the one who encountered the issue reported in b5.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) batteries would not charge.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 Name
CARDIOSAVE HYBRID TYPE B PLUG
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
arelean guzman
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10835940
MDR Text Key217427154
Report Number2249723-2020-01908
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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 Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 08/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
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
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/13/2020
Supplement Dates Manufacturer Received11/25/2020
08/18/2022
Supplement Dates FDA Received12/15/2020
08/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/13/2016
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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