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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 Battery Problem (2885)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
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) displayed, "unusable battery detected in bay one." 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 the cardiosave intra-aortic balloon pump (iabp) displayed, "unusable battery detected in bay one." 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) evaluated the iabp unit and was able to reproduce the reported issue.The fse switched battery 1 to battery 2 and problem followed battery 1 into bay 2.He fse found the issue to be the battery, and replaced both batteries as warranty and to keep expiration dates together.The fse then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.
 
Manufacturer Narrative
Updated fields: b3, b4, b5, d4 (model#), e2, e3, g2, g3, g6, h2, h6 (health effect - clinical code, type of investigation, component codes, health effect - impact codes), h10.
 
Event Description
It was reported that prior to use, the cardiosave intra-aortic balloon pump (iabp) displayed, "unusable battery detected in bay one." there was no patient involvement, and 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
MDR Report Key11065786
MDR Text Key226017737
Report Number2249723-2020-02211
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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
Type of Report Initial,Followup,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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