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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-52
Device Problems No Display/Image (1183); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) units screen has gone black and is not working at all.There was no patient harm reported.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) units screen has gone black and is not working at all.Additional information received indicated the iabp shut down and stopped working mid way through therapy while on mains power.There was no patient harm reported.
 
Event Description
N/a.
 
Manufacturer Narrative
Additional fields: e1 (event site state: (b)(6), event site postal code: (b)(6)).It was reported that the cardiosave intra-aortic balloon pump (iabp) shut down while in use on patient - no reported harm to patient.No patient details available.A getinge field service engineer (fse) inspected system mains power ok, battery packs fully charged but system would not power up.The power management pcb was found to be fluid damaged but no fluid found in unit.Replaced power management pcb - system fully tested and returned to department.Ebme contact (b)(6) reported by (b)(6) (b)(4).
 
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Brand Name
CARDIOSAVE HYBRID, TYPE G 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 Key17710090
MDR Text Key322939498
Report Number2249723-2023-03981
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108438
UDI-Public10607567108438
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 04/04/2024
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 Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2023
Initial Date FDA Received09/08/2023
Supplement Dates Manufacturer Received01/25/2024
04/03/2024
Supplement Dates FDA Received02/14/2024
04/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2013
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
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