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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 Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: the fse inspected the toucchscreen and found damage to the screen protector. To fix the issue, the fse replaced the touchscreen, and noted that the iabp unit then passed the touchscreen calibration. The fse then completed pm service including all functional and safety checks. All testing passed to factory specifications and the iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted upon completion of our investigation. (b)(6).
 
Event Description
It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) failed touchscreen calibration. 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 Key12668738
MDR Text Key277722829
Report Number2249723-2021-02399
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 Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
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 Received06/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2019
Is the Device Single Use? No
Type of Device Usage Reuse

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