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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 Problem Output below Specifications (3004)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) was dispatched to evaluate the iabp. The stm was unable to reproduce the reported issue; however the stm did note several "low vacuum" alarms, no faults were reported in the fault journal. The stm ran performance test several times and the average vacuum hovered around 195mmhg; however one reading of 176mmhg was reported. The stm installed a 5000hr kit and rebuilt the iabp. The heads and diaphragms showed no unusual wear. The stm then ran performance tests several times and the average vacuum was bumped to 200mmhg. The stm ran the iabp at 130bpms for half an hour and retested; the average vacuum raised above 163mmhg. The stm validated the calibration and all functional and safety tests were performed and passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) alarmed low vacuum. It is unknown under which circumstances this event occurred or if there was any patient involvement; however there was 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 Key8795395
MDR Text Key151201126
Report Number2249723-2019-01112
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,user f
Reporter Occupation
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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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