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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH PRODUCT NOT IN LIST - IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH PRODUCT NOT IN LIST - IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number PRODUCT NOT IN LIST - IABP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 04/13/2021
Event Type  Injury  
Manufacturer Narrative
The getinge field service engineer reported that there was no malfunction of the iabp.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy the customer had seen blood inside the helium tubing. The patient was stable. The customer was advised to disconnect the iab from the console and remove the iab from the patient. Upon follow up approximately 40 minutes later. The iab still had not been removed. The console was in standby. The customer was advised to disconnect the helium tubing and power down the console. Cardiac surgeon was asked to assist removing required cut down and removal with "significant resistance". Pathology reports material in the iabp was desiccated thrombus. There was no malfunction of the iabp (intra-aortic balloon pump). Iab complaint reported under mfg report# 2248146-2021-00283.
 
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Brand NamePRODUCT NOT IN LIST - 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
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11904336
MDR Text Key265001924
Report Number2249723-2021-01139
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPRODUCT NOT IN LIST - IABP
Device Catalogue NumberUNKNOWN
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 Received05/06/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/28/2021 Patient Sequence Number: 1
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