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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Overheating of Device (1437)
Patient Problems Tachycardia (2095); No Consequences Or Impact To Patient (2199)
Event Date 12/26/2019
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during use on a patient an overheat alarm occurred on a cardiosave intra-aortic balloon pump (iabp) and pumping was stopped. Patient who started using iabp on (b)(6) 2019 at 13:00, said that at night, hr 130bpm to 150bpm and tachycardia was present and the situation was unstable. At around 6:30 am on the (b)(6), a nurse was treating the patient, and the iabp sounded an alarm, the nurse saw the message "overheat" and confirmed that pumping was not being performed. He called dr and pressed the start button, but it did not work and contacted clinical engineering and made trial and error. Six minutes later, the power was turned on and off and the start button was pressed to resume pumping. No effect on patients health. V-a ecmo was used. After about 8am, we decided to exchange with cs300 after consulting with day shift staff. A replacement iabp was brought in for cardiosave at 12:00 and checked the situation and exchanged it for the target machine. There was no harm or injury to patient an no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
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
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key9597963
MDR Text Key191680089
Report Number2249723-2020-00087
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2014
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: 01/16/2020 Patient Sequence Number: 1
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