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U.S. Department of Health and Human Services

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

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DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Manufacturer Narrative
Testing of actual/suspected device: (10) a getinge field service engineer evaluated the unit and was unable to duplicate the alarm.The fse confirmed the helium regulator calibration was reading low and re-adjusted the helium regulator to specs.The unit passed all functional and safety test per factory specifications.The iabp was than released to the customer and cleared for clinical use.A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) displayed a catheter restriction alarm.There was no harm or injury to the patient and no adverse event was reported.
 
Manufacturer Narrative
Updated fields - b4, e1(site country), e2, e3, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10.
 
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Brand Name
CARDIOSAVE HYBRID DOMESTIC
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 Key14395254
MDR Text Key291616126
Report Number2249723-2022-01114
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
Report Date 04/02/2024
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
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/20/2022
Initial Date FDA Received05/13/2022
Supplement Dates Manufacturer Received04/01/2024
Supplement Dates FDA Received04/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2015
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
UNKNOWN IAB
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