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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 Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 08/04/2022
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that, the cardiosave intra-aortic balloon pump (iabp) units ecg adaptor is broken.It is unknown under which circumstances the issue was discovered or if there was any patient involvement.
 
Event Description
It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) units ecg adaptor is broken.
 
Manufacturer Narrative
Updated field: b4, d9, e1-(site country), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusion, investigation conclusions),h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) had a issue of ecg adaptor is broken and can't plug in.A getinge field service engineer evaluated the unit and confirmed - ecg ext plug is damaged.Possible obstruction or damaged pin socket won't allow the ecg cable to plug in.Fse replaced front end board.Re calibrated 30 psi and tested.Repair successful.Performed all functional tests and calibrated system.Note pm was due in september 2022.Pm was performed after repair was completed.For checklist see pm service report so# (b)(4) (attached).Cleared for clinical use.
 
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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key15236132
MDR Text Key304899205
Report Number2249723-2022-02090
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 Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/29/2024
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 08/04/2022
Initial Date FDA Received08/16/2022
Supplement Dates Manufacturer Received12/15/2022
03/28/2024
Supplement Dates FDA Received01/04/2023
03/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
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