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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 Battery Problem (2885); Charging Problem (2892)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon receipt of further information.Device not returned to manufacturer.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) battery would not fully charge and took time to charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
Manufacturer Narrative
Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted if this information is provided to us.
 
Event Description
It was reported that the battery of the cardiosave intra-aortic balloon pump (iabp) would not fully charge.Charging stops halfway, and it takes time to charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was 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.To fix the issue, the fse replaced the power management board, and 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.
 
Event Description
It was reported that the battery of the cardiosave intra-aortic balloon pump (iabp) would not fully charge.Charging stops halfway, and it takes time to charge.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
 
Manufacturer Narrative
Updated fields: b4, b6, b7, d10, g2, g3, g6, g7, h2, h10, h11.Corrected fields: b5, d1, d4(model#, catalog# & udi#), d5, g1(contact person), h6(impact codes).
 
Event Description
It was reported that during use the battery of the cardiosave intra-aortic balloon pump (iabp) would not fully charge.Charging stops halfway, and it takes time to charge.There was no harm or injury to the patient and no adverse event was reported.
 
Event Description
N/a.
 
Manufacturer Narrative
Updated fields; b4, g3, g6, h2, h4, h6, h10.
 
Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h10, h11 corrected fields: h4.
 
Event Description
N/a.
 
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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 Key10818880
MDR Text Key216219449
Report Number2249723-2020-01878
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
Combination Product (y/n)N
Reporter Country CodeJA
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 Other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient SexPrefer Not To Disclose
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