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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Inability to Auto-Fill (1044); Output below Specifications (3004)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2020
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. The customer biomed ran condensate removal several times, replaced purge filter, purge manifold and installed 2. 5k pm kit. A getinge service territory manager (stm) was dispatched to evaluate the iabp. The stm powered the unit on, connected known trainer, known intra-aortic balloon(iab), and initiated autofill. The unit successfully completed autofill, began pumping, and ran for several minutes. The stm then entered the iabp diagnostics and noticed that the vacuum specifications within the pneumatic performance test were not within specification with service manual. To address the issue, the stm installed a 5000 hour pm kit supplied by the customer and attempted to complete a safety disk leak test. Subsequently, the test failed and the safety disk was replaced with part supplied by customer. The stm powered unit on in normal mode and initiated autofill, the unit alarmed within 5 seconds with a system failure alarm. The fault log revealed a critical failure with k8. The stm determined that the drive manifold is faulty and needs to be replaced. The stm presented the customer with an estimate for repairs and the customer declined repair. The stm later received a communication from the customer stating that repair is being declined at this time. The customer advised they will be removing the device from service and moving forward with the purchase of a cardiosave. Unit is in a state of disrepair at this time and is not cleared for clinical use.
 
Event Description
It was reported by the customer that during use on a patient, the cs300 intra-aortic balloon pump (iabp) displayed an autofill and low vacuum failure. The iabp was swapped out without incident. There was no patient harm or injury and no adverse event reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key10039098
MDR Text Key190506217
Report Number2249723-2020-00732
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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