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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Manufacturer Narrative
The initial reporter named in is a getinge employee who has different contact details from that of the event site. (b)(6). The getinge field service engineer (fse) that encountered the issue, replaced the pneumatic interface module assembly, rohs (0997-00-1178) and then it was tested multiple times. It passed each time without any further issues. Subsequently, the preventive maintenance (pm) was completed. The unit passed all functional and safety tests per factory specifications. The iabp was released to the customer and cleared for clinical service. Upon completion of our investigation, a supplemental report will be submitted.
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the pim test failed repeatedly in the cardiosave intra-aortic balloon pump (iabp). There was no patient involvement, and no adverse event 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 Key12835899
MDR Text Key282270168
Report Number2249723-2021-02673
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
Remedial Action Other
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2021
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 Received10/29/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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