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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 No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/29/2023
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit screen display went blank.Therapy continued on the same device once the screen came back on.There was no patient injury or harm reported.
 
Manufacturer Narrative
Updated fields: d9(device available for eval, return to manufacture date), h6 (type of investigation, investigation findings, component codes and investigation conclusions).A getinge field service engineer (fse) evaluated and could not duplicate the reported issue of screen going blank during use.Fse found error code 118 close to reported date of event.Fse replaced video generator board.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing department received parts associated with this complaint, this part was received with a reported unit failure message of display went black while in use.Performed visual inspection of this part received and part looks to be in good condition.The failure analysis and testing department could not verify the failure of black display.The failure analysis and testing department performed all calibration tests and pumped the unit for 2 hours and did not observe any intermittent with display.Video gen.Board passed testing.Sending board to the supplier as per procedure 0002-07-d008 rev ap.The non-conformances with the returned components were not confirmed.Therefore, the root cause is not confirmed.The fat dept.Received part number video gen.Board from the supplier.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The supplier found that fct failed due to a touch screen error.The supplier replaced u41 and thermal pad, then retested fct, and passed.See attached document for investigation received from the supplier.The failure analysis and testing dept.Installed exec.Processor board, into the cardiosave test fixture and tested the board to factory specifications per procedure number 0002-07-d016 revision e and the cardiosave service manual part number 0070-00-0639 revision r.The board passed testing.Retaining the board in the fat per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
 
Event Description
N/a.
 
Manufacturer Narrative
A getinge field service engineer (fse) evaluated and could not duplicate the reported issue of screen going blank.Fse found error code 118 close to reported date of event.Fse replaced video generator board.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing department received video gen.Board.This part was received with a reported unit failure message of display went black while in use.Performed visual inspection of this part received and part looks to be in good condition.Installed the video gen.Board into the cardiosave test fixture and tested to the factory specifications and the cardiosave service manual.The failure analysis and testing department could not verify the failure of black display.The failure analysis and testing department performed all calibration tests and pumped the unit for 2 hours and did not observe any intermittent with display.Video gen.Board passed testing.Sending board to the supplier as per procedure 0002-07-d008 rev ap.The fat dept.Received part number video gen.Board from the supplier.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The supplier found that fct failed due to a touch screen error.The supplier replaced u41 and thermal pad, then retested fct, and passed.See attached document for investigation received from the supplier.The failure analysis and testing dept.Installed video gen.Board, into the cardiosave test fixture and tested the board to factory specifications per procedure number 0002-07-d016 revision e and the cardiosave service manual part number 0070-00-0639 revision r.The board passed testing.Retaining the board in the fat per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
 
Event Description
N/a.
 
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Brand Name
CARDIOSAVE HYBRID, TYPE B 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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key17700797
MDR Text Key322867682
Report Number2249723-2023-03961
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/30/2024
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 Health Professional
Device Model Number0998-00-0800-53
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/29/2023
Initial Date FDA Received09/07/2023
Supplement Dates Manufacturer Received05/21/2024
05/30/2024
Supplement Dates FDA Received05/22/2024
05/30/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2022
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN.
Patient SexPrefer Not To Disclose
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