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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-55
Device Problems Display or Visual Feedback Problem (1184); Failure to Calibrate (2440)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and was able to reproduce the reported issue.The fse found that the touch screen was still not working correctly and the buttons had to be pressed repeatedly for a response.Furthermore, the fse found related fault codes #63 and # 64 recorded in the logs.No visible mechanical damages of the panel was observed.The fse ordered a replacement touchscreen assembly, 12.1¿, and upon receipt, repairs can continue.Additional information is being requested with regard to the repair and status of the iabp unit.A supplemental report will be submitted when this information is provided to us.The full event site name is (b)(6).
 
Event Description
It was reported that during routine check, the cardiosave intra-aortic balloon pump (iabp) touchscreen panel was very rigid in responding and required the end user to press the buttons repeatedly.It was also reported that as a result of the touchscreen panel issue, calibration of the touch screen had to be performed several times until it was completed.Additionally, electrical test failure #6 was reported to have appeared after start-up.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
The fse resolved the reported issue by replacing the touchscreen assembly, 12.1¿, seal, display.125 x.200 x 5.0, seal,display.030 x.200 x 2.2, seal,display.030 x.200 x 9.6, seal dip,.059 x100 x7.45, and seal dip,.059 x100 x10.07.The fse performed functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period may 2019 through apr 2021 was reviewed.There were no triggers identified for the review period.
 
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Brand Name
CARDIOSAVE HYBRID INT TYPE E/F PLUG
Type of Device
SYSTEM, 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 Key11731950
MDR Text Key247561450
Report Number2249723-2021-00877
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108414
UDI-Public10607567108414
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K112372
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-55
Device Catalogue Number0998-00-0800-55
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/06/2021
Initial Date FDA Received04/27/2021
Supplement Dates Manufacturer Received02/10/2022
Supplement Dates FDA Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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