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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Thermal Decomposition of Device (1071); Loss of Power (1475); Computer Operating System Problem (2898); Inappropriate or Unexpected Reset (2959)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2018
Event Type  malfunction  
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 getinge field service engineer is evaluating the iabp. The fse performed running test in the getinge office. The iabp monitor display was blacked out. The reported incident was duplicated and the fse will be replacing the solenoid control board and the power management board. The iabp unit is still under investigation. More information will be provided when the fse receives parts from service. Additional information has been requested, and we will report accordingly if it becomes available. The full name of the event site name noted, is (b)(6).
 
Event Description
It was reported that during patient therapy, the cardiosave intra-aortic balloon pump (iabp) had shutdown and suddenly the unit had a burnt smell. Although the customer tried to reboot the unit, it could not reboot. The customer reported the iabp beeped repeatedly. The customer turned off ac power supply and removed battery. The iabp unit was replaced with another cardiosave to continue therapy. The batteries were restored after surgery and the iabp was turned off. However after a while, the pump turned on and rebooted unexpectedly and an alarm beeped repeatedly. The batteries were removed again and the iabp was turned off forcibly. No patient injury or harm was reported.
 
Manufacturer Narrative
The getinge field service engineer (fse) replaced the power management board and the solenoid driver board which resolved the issue. All functional and safety tests were performed to meet factory specifications and the iabp was returned to the customer and cleared for clinical use.
 
Event Description
It was reported that during patient therapy, the cardiosave intra-aortic balloon pump (iabp) had shutdown and suddenly the unit had a burnt smell. Although the customer tried to reboot the unit, it could not reboot. The customer reported the iabp beeped repeatedly. The customer turned off ac power supply and removed battery. The iabp unit was replaced with another cardiosave to continue therapy. The batteries were restored after surgery and the iabp was turned off. However after a while, the pump turned on and rebooted unexpectedly and an alarm beeped repeatedly. The batteries were removed again and the iabp was turned off forcibly. No patient injury or harm was reported.
 
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Brand NameCARDIOSAVE
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 Key7916171
MDR Text Key122163844
Report Number2249723-2018-01672
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 11/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2018
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? No
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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