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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  malfunction  
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
 
Event Description
It was reported that a getinge field service engineer (fse) ordered two helium regulators for stock for cardiosave intra-aortic balloon pump (iabp), and upon receipt, it was clear from the packaging that one of the regulators was used.There was no malfunction of the iabp unit reported.There was no patient involvement, and no adverse event reported.
 
Manufacturer Narrative
Updated fields: b4, d9, e1(site country), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.It was reported that a getinge field service engineer (fse) ordered two helium regulators for stock for cardiosave intra-aortic balloon pump (iabp), and upon receipt, it was clear from the packaging that one of the regulators was used.There was no malfunction of the iabp unit reported.There was no patient involvement, and no adverse event reported.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.In order to reproduce the failure, the suspect high pressure helium regulator was installed in the cardiosave test fixture.The following test was performed - leak test (sniffer) (seq.(b)(6)).Results : pass.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.
 
Event Description
N/a.
 
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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 Key16258287
MDR Text Key308539797
Report Number2249723-2023-00644
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/22/2024
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 Other
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/30/2021
Initial Date FDA Received01/27/2023
Supplement Dates Manufacturer Received03/19/2024
Supplement Dates FDA Received03/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2020
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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