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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Pumping Stopped (1503); Inappropriate or Unexpected Reset (2959); Appropriate Term/Code Not Available (3191)
Patient Problems Nausea (1970); No Consequences Or Impact To Patient (2199)
Event Date 11/11/2018
Event Type  Injury  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The customer has not requested getinge to evaluate the iabp in connection with this event. However, the customer has advised that they evaluated the unit and the compressor was cleaned. Preventative maintenance (pm) was performed because it was due, and all testing passed. There were no parts replaced. The unit was then hooked up with a trainer and ran overnight without issue. The unit then was released for clinical use.
 
Event Description
It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) went into standby mode 3 times before it was switched out with another iabp. There was no patient harm and 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 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 Key8131546
MDR Text Key129604742
Report Number2249723-2018-02112
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 05/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2018
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/18/2015
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: 12/04/2018 Patient Sequence Number: 1
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