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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Failure to Power Up (1476); Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 01/20/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) 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. Additional information has been requested, and we will report accordingly when it becomes available.
 
Event Description
It was reported that before use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated "power-up test fails # 10", and the helium transducer was not calibrated. There was no patient involvement, and there was no adverse event reported.
 
Manufacturer Narrative
The getinge authorized distributor has evaluated the unit and has determined that the executive processor board is defective and needs to be replaced. However, the repairs have not yet been completed ,as the distributor is awaiting the purchase order from the customer to complete the repairs. Consequently, the unit is not in clinical use.
 
Event Description
It was reported that before use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated "power-up test fails # 10", and the helium transducer was not calibrated. There was no patient involvement, and there was no adverse event reported.
 
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Brand NameCARDIOSAVE HYBRID
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8335752
MDR Text Key138165684
Report Number2249723-2019-00229
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 07/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-0800-52
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No

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