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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-52
Device Problems Device Emits Odor (1425); Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during a routine daily check performed by the customer, the cardiosave intra-aortic balloon pump (iabp) unit had a fiber-optic sensor failure and a burning rubber smell this morning which has since gone away.There was no patient involvement.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE G 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 Key18313146
MDR Text Key330302372
Report Number2249723-2023-05270
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108438
UDI-Public10607567108438
Combination Product (y/n)N
Reporter Country CodeUK
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 Nurse
Type of Report Initial
Report Date 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0998-00-0800-52
Device Catalogue Number0998-00-0800-52
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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