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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed. There were no non-conformance's in the production dhr related to the reported event. A getinge field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and was unable to duplicate the reported problem. Fault #53 was logged into error logs twice. The fse opted to replace the fiber optic module assembly as a preventative measure. Diagnostic tests were performed and all operations were good. The iabp unit was returned to the customer for clinical use.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) was unable to calibrate the fiber optic sensor module a couple of times and there was no waveform. Three different intra-aortic balloons were used before the iabp was swapped out with another iabp unit. There was no patient harm and no adverse event was reported.
 
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Brand NameCARDIOSAVE HYBRID TYPE B PLUG
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 Key8189788
MDR Text Key131341492
Report Number2249723-2018-02192
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
Report Date 12/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
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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