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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH UNKNOWN INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH UNKNOWN INTRA-AORTIC BALLOON PUMP (IABP) SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number UNKNOWN
Device Problem Inability to Auto-Fill (1044)
Patient Problem Ischemia (1942)
Event Date 05/22/2021
Event Type  Injury  
Manufacturer Narrative
At this time, the customer has not requested for getinge to evaluate the iabp unit involved in this event. Attempts are being made to obtain additional information, and a supplemental report will be submitted if additional information is provided. The full name of the event site was shortened due to field character limit; the full name is (b)(6). Not returned to manufacturer.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) generated an autofill failure and would not inflate causing ischemia to the patient. It was later reported that the ischemia in the patient's leg was related to his general condition. At this time, the customer has not attributed the event to the iabp unit involved.
 
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Brand NameUNKNOWN INTRA-AORTIC BALLOON PUMP (IABP)
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 Key12035767
MDR Text Key257398189
Report Number2249723-2021-01317
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeEG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/08/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/21/2021 Patient Sequence Number: 1
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