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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-32
Device Problems Break (1069); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that when checking the cardiosave intra-aortic balloon pump (iabp) with a non-sterile demo catheter, the adapter for the catheter extension was previously loosened with a clamp when trying to unscrew it.The pneumatic module was destroyed.There was no patient involvement.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
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Brand Name
CARDIOSAVE HYBRID TYPE J 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 Key18133266
MDR Text Key328073297
Report Number2249723-2023-04859
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567111117
UDI-Public10607567111117
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-32
Device Catalogue Number0998-00-0800-32
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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