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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 Problems Emotional Changes (1831); Low Blood Pressure/ Hypotension (1914)
Event Date 03/04/2021
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit cannot be reviewed per sop since the serial number for the unit was not provided. The customer has not requested any repair to intra-aortic balloon pump. Further information has been requested. A supplemental report will be submitted if additional information is provided. Not returned to manufacturer.
 
Event Description
The customer reported that while in use on a patient, the intra-aortic balloon pump (iabp) indicated a ¿high pressure alarm¿ and reportedly ¿shut off¿. The and blood ¿quickly filled helium tubing¿ of the intra-aortic balloon (iab). The patient reportedly became hemodynamically unstable, symptomatic (pale, anxious and dizzy) and a new iab catheter via axillary access was inserted, the initial iab catheter was removed. Upon examination the removed iab catheter had a ¿broken wire and blood in the helium tubing¿. The patient¿s age medical history and indication for use were not provided. The iabp s/n is not known at this time. The ruptured balloon event reported in a separate mdr.
 
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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
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key11585318
MDR Text Key242903300
Report Number2249723-2021-00655
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,user f
Reporter Occupation
Type of Report Initial
Report Date 03/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
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: 03/29/2021 Patient Sequence Number: 1
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