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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 Problems Backflow (1064); Device Contamination with Body Fluid (2317)
Patient Problem Injury (2348)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint. There is no any issue with the pump. At this time, the customer has not requested getinge to evaluate the iabp. Additional information is being requested from the customer with regard to the repair and status of the iabp. A supplemental report will be submitted if this information is provided to us. Device not returned to manufacturer.
 
Event Description
It was reported that during off-label use on a patient with an intra-aortic balloon (iab) inserted into the right subclavian artery, blood was observed to be backing up into the helium tubing of the intra-aortic balloon pump (iabp). The patient was taken to the cardiac cath lab for removal of the iab and it was noted that there was difficulty in removing the iab from the patient. Subsequently, the patient was taken to the cardiovascular operating room (cvor) for ¿cut down¿ removal of the iab by a surgeon. The iabp unit was turned off and the patient was reported to be in stable condition. Please refer to related mfg report number 2248146-2020-00032 on the involved intra-aortic balloon (iab).
 
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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 Key9618418
MDR Text Key176097874
Report Number2249723-2020-00114
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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? No
Event Location No Information
Date Manufacturer Received01/23/2020
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: 01/22/2020 Patient Sequence Number: 1
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