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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 Device Inoperable (1663); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/31/2017
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) evaluated the intra-aortic balloon pump (iabp) and was unable to duplicate the customer's complaint. The fse confirmed that there was no failure of the iabp touchscreen and that it worked normally. However, the fse cleaned the plug body of the coiled cord and connector with flux remover, aerosol and aerosol duster, and performed all functional and safety tests to factory specifications. The iabp was returned to the customer for clinical use.
 
Event Description
Customer reported that while in use on a patient, the (b)(4) intra-aortic balloon pump (iabp) touchscreen did not respond to some inputs (the timing menu not possible to open). However, the iabp continued to provide therapy but was subsequently replaced. No death or injury was reported.
 
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 (fse) evaluated the iabp and replaced complete display. The iabp's touchscreen then worked normally, and the iabp passed all functional and safety tests to factory specifications and was returned to clinical service.
 
Event Description
Customer reported that while in use on a patient, the cardiosave intra-aortic balloon pump (iabp) touchscreen did not respond to some inputs (the timing menu not possible to open). However, the iabp continued to provide therapy but was subsequently replaced. No death or injury 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 Key6876953
MDR Text Key104053089
Report Number2249723-2017-00499
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeBE
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 12/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2017
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 Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2013
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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