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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
Catalog Number 0998-00-0800-53
Device Problem Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. A getinge service territory manager (stm) had the customer try to calibrate the iabp but had mixed results. The evaluated the iabp himself and was able to successfully calibrate the iabp. The stm could not duplicate the touchscreen intermittently responding. However, the stm did receive and error code #139 while testing the iabp. He reseated all the boards and connections. The stm also replaced the touch panel assembly since the reported issue was intermittent. The stm then completed full functional and safety checks to specification. The iabp was then returned to the customer for clinical use.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a touchscreen issue as it was unable to calibrate. No patient was involved during this event and no adverse event was reported.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a touchscreen issue as it was unable to calibrate. No patient was involved during this event and no adverse event 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 Key7456029
MDR Text Key106599466
Report Number2249723-2018-00693
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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?
Event Location No Information
Date Manufacturer Received07/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2017
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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