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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
There was no reported malfunction of the iabp unit in question, and customer has not requested getinge to evaluate the unit. Additionally, the iabp model and serial number was not provided to us. However, information has been requested, and if provided, a supplemental report will be submitted.
 
Event Description
Customer reported that post intra-aortic balloon pump (iabp) therapy they met resistance when removing the intra aortic balloon catheter (iabc). The customer reported that they "slightly enlarged the incision and when removing the catheter they noted a clot in the iabc". The pump model was not reported; however, the customer reported that there were no issues during therapy with the iabp, thus no reported malfunction of the iabp. The patient's injury is not attributed to the iabp. Refer to mfg report number 2248146-2020-00422 for information of the involved balloon catheter.
 
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Brand NameUNKNOWN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10425394
MDR Text Key203491081
Report Number2249723-2020-01299
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/19/2020 Patient Sequence Number: 1
Treatment
SENSATION PLUS 8FR. 50CC IAB
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