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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/12/2022
Event Type  malfunction  
Manufacturer Narrative
The initial reporter named is a getinge employee who has different contact details from that of the event site. A contact person at the event site is (b)(6). Testing of actual/suspected device: while completing the preventative maintenance (pm), it was discovered that there was evidence of a previous blood back. It was also discovered that the upper panel assembly had sustained previous damage. The fse completed the repairs in addition to the the full pm, calibration, safety, and functionality checks were completed per the service manual. All checks were passed per the factory specifications. The device is functioning in accordance with factory specifications at this time and is cleared for clinical use. A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) there was noted evidence of a blood back on the cardiosave intra-aortic balloon pump (iabp). There was no patient involvement, 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 CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 
MDR Report Key13455811
MDR Text Key289495345
Report Number2249723-2022-00222
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse

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