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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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Event Description
It was reported to the getinge field service engineer (gfse) while on site servicing another unit, that the cardiosave intra-aortic balloon pump (iabp) unit would not slave out to the patient monitor.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
Complaint record being cancelled as it is a duplicate to tw# (b)(4);mfg report number 2249723-2024-00388.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.
 
Event Description
Complaint record being cancelled as it is a duplicate to tw# (b)(4);mfg report number 2249723-2024-00388.
 
Event Description
It was reported to the getinge field service engineer (gfse) while on site during a routine testing of the unit, that the cardiosave intra-aortic balloon pump (iabp) unit would not slave out to the patient monitor.There was no patient involvement.
 
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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 Key18686887
MDR Text Key335143716
Report Number2249723-2024-00587
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/15/2024
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 02/01/2024
Initial Date FDA Received02/12/2024
Supplement Dates Manufacturer Received02/20/2024
03/15/2024
Supplement Dates FDA Received02/22/2024
03/15/2024
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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