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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that while being performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) units helium bottle can not be used with spare part.There was no patient involvement.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
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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 Key18075448
MDR Text Key327428844
Report Number2249723-2023-04753
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Date Manufacturer Received10/19/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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