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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 Problems Power Problem (3010); Unexpected Shutdown (4019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) was dispatched to investigate. The stm evaluated the iabp unit but was unable to duplicate the customer's reported issue. The stm noted that the log files indicated that the iabp unit has switched back and forth from the bulk power source to the battery source very quickly several times. The stm suspected an intermittent issue with the power management board and the stm replaced the power management board as a precautionary measure. Subsequently, the stm verified the battery runtime then completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. The suspected faulty power management board has been requested back for further evaluation. A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) shutdown. When the iabp unit was rebooted, it was noted that ac power was not recognized. It was also noted that when the iabp unit was removed from the cart, "rescue mode" lit up. The iabp unit was swapped out to continue therapy. There was no patient harm or adverse event 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 Key9491055
MDR Text Key191391335
Report Number2249723-2019-02062
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
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2019
Is this an Adverse Event Report? No
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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