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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE MAHWAH UNKNOWN SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)
Event Date 12/20/2017
Event Type  Death  
Event Description
It was reported that a patient that presented with non-st elevation myocardial infarction (nstemi) and left main disease, went into cardiogenic shock. Two vasopressors were started and the patient's blood pressure was still not reading. An unspecified iabp was recruited for use as a replacement after the 1st iabp was taken out of service. After the patient was being supported on the second iabp, a ¿no trigger/unable to calibrate warning message appeared. The staff switched to the transduced central lumen for pressures and the iabp worked normally. It was later reported that the patient died two (2) days later. The facility does not attribute the patient's death to the iabp. Service was performed and no issues were found with the iabp. This report is for the 2nd iabp used during this event; also related to iab reported submitted under mfg report number 2248146-2018-00027.
 
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. At this time, the customer has not requested getinge to evaluate the iabp. If additional information is made available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient that presented with non-st-elevation myocardial infarction (nstemi) and who also had left main disease, went into cardiogenic shock. An unknown intra-aortic balloon pump (iabp) was being used which displayed a "no trigger" warning message after the first one was switched out. The ecg was switched in order to work. The iabp was taken out of service. Service was performed and no issues were found with this iabp. It was also reported that the patient expired five (5) days later. The facility does not attribute the death to the iabp. This report is for the 2nd iabp used in therapy which is referenced under tw # (b)(4).
 
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Brand NameUNKNOWN
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7182544
MDR Text Key104277666
Report Number2249723-2018-00049
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 03/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
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?
Device AgeYR
Event Location No Information
Date Manufacturer Received02/13/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/11/2018 Patient Sequence Number: 1
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