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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 Communication or Transmission Problem (2896)
Patient Problem Insufficient Information (4580)
Event Date 12/28/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that when preparing for use, the cardiosave intra-aortic balloon pump (iabp) had a fault code 78 and 116.
 
Event Description
The complaint is being cancelled as it has been opened in error.
 
Manufacturer Narrative
The complaint is being cancelled as it has been opened in error.Revert all sections to blank : b.Adverse event or product problem d.Suspect medical device e.Initial reporter g.All manufacturers h.Device manufacturers only.
 
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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 Key18455403
MDR Text Key332500463
Report Number2249723-2024-00061
Device Sequence Number1
Product Code DSP
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
Report Date 04/24/2024
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/05/2024
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received04/24/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
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