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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INTERNATIONAL TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Pumping Stopped (1503); No Audible Prompt/Feedback (2282)
Patient Problem Bradycardia (1751)
Event Date 11/10/2020
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit by cleaning and performing preventative maintenance (pm) including all system checks, calibrations, electrical safety tests, and cleaning and operation check of the sensor module. All testing was performed per factory specifications; however, no anomalies or malfunction was found on the iabp unit. The iabp unit was cleared for clinical use and returned to the customer.
 
Event Description
It was reported during use, the alarm for the cardiosave intra-aortic balloon pump (iabp) did not sound even though the drive was stopped frequently while driving the iabp unit. Upon hearing the situation, the patient had bradycardia and the signal output from the bedside monitor, which is the signal output source, was unstable, so the ecg signal to the iabp was unstable (with or without r wave). It was reported that the iabp had been placed in semi-auto operation mode with the external monitor input by setting up an ecg source. It was later reported that the patient was in stable condition with the intra-aortic balloon (iab) frequency being set at 1:2. It was assumed that the iabp drive was temporarily stopped. However, the hospital took the equipment outage seriously, recognized it as a medical accident. Patient therapy was completed with no adverse consequence to the patient reported. It is unknown if the patient¿s injury is attributed to the iabp. Cardiosave iabp ecg (r iabp ggj iabp 11/12. This is an automated draft translation - if any uncertainty contact the local ssu immediately: complaint that the alarm did not sound even though the drive was stopped frequently while driving cardiosave. Upon hearing the situation, the patient had bradycardia and the signal output from the bedside monitor, which is the signal output source, was unstable, so the ecg signal to the iabp was unstable (with or without r wave). ), so it was assumed that the iabp drive was temporarily stopped. However, the hospital took the equipment outage seriously, recognized it as a medical accident, and asked ggj to inspect the iabp drive unit. Inspection will be carried out on 11/12.
 
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Brand NameCARDIOSAVE HYBRID INTERNATIONAL TYPE B PLUG
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10953774
MDR Text Key221280694
Report Number2249723-2020-02072
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
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-65
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 Received03/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2019
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: 12/05/2020 Patient Sequence Number: 1
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