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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 Output below Specifications (3004); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2019
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as 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 the customer's site for a previously reported issue. The stm evaluated the iabp unit and was able to duplicate the customer's reported issue of a low vacuum alarm. The stm tested in diagnostics and observed the k7 solenoid on the drive manifold assembly was inoperative and not activating the vacuum side of the compressor. The stm troubleshot the k7 solenoid and removed and installed a new drive manifold assembly which corrected the reported issue. Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer. (b)(6).
 
Event Description
It was reported that during use on a patient via axillary insertion, the cs300 intra-aortic balloon pump (iabp) alarmed and displayed a "vacuum alarm" on the screen. Within a minute or two the alarm changed to "suction alarm," and within a few minutes after that the alarm again changed to "system malfunction" and the iabp unit powered off. It was noted that all alarms occurred within a span of five minutes with the iabp unit plugged in the entire time. The end user quickly swapped out the iabp unit without issue and noted that no harm was caused to the patient. After removal from the patient, the end user turned the iabp unit on to check the battery and noted that the battery was full. The iabp unit was sent to the customer's biomed for further evaluation. There was no harm or injury to the patient and no adverse event was 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 Key9576560
MDR Text Key191579025
Report Number2249723-2020-00060
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
Type of Report Initial
Report Date 01/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2020
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 Received12/19/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2007
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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