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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-65
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2022
Event Type  malfunction  
Manufacturer Narrative
Type of investigation not yet determined: additional information is being requested in regards to whether or not the customer has requested for getinge to service the iabp unit involved. A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during a in hospital inspection the cardiosave intra-aortic balloon pump (iabp) had a negative pressure shortage. There was no patient involvement, and no adverse event reported.
 
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Brand NameCARDIOSAVE
Type of DeviceSYSTEM, 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
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key14214099
MDR Text Key290543175
Report Number2249723-2022-00941
Device Sequence Number1
Product Code DSP
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 Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-65
Device Catalogue Number0998-00-0800-65
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse

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