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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2018
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 supplemental report will be submitted when subsequent information is provided.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) generated a low vacuum alarm. It is unknown under which circumstances this event occurred or if there was a patient involved; however, there was no adverse event reported.
 
Manufacturer Narrative
A getinge service territoy manager (stm) evaluated the iabp and discovered that the customer installed the 2500 kit incorrectly which created the reported issue; the seals were installed, but one of the vacuum heads was 180 degrees off and was creating pressure instead of vacuum. The fse reseated the vacuum head to the correct position and checked for vacuum. The fse then performed all calibrations, functional and safety checks as per factory specifications. The iabp passed all tests performed and was returned to the customer and cleared for clinical use.
 
Event Description
It was reported that during a routine replacement of the safety disk by the customer after they had performed preventative maintenance (pm) and installed the 2500 hour kit, the cs300 intra-aortic balloon pump (iabp) generated a "low vacuum" alarm. There was no patient involvement and no adverse event was reported.
 
Manufacturer Narrative
The stm that performed the pm returned to the site to evaluate the unit and discovered that the seals were installed correctly, but one of the vacuum heads was 180 degrees off and was creating pressure instead of vacuum. The fse reseated the vacuum head to the correct position and checked for vacuum. The fse then performed all calibrations, functional and safety checks as per factory specifications. The iabp passed all tests performed and was returned to the customer and cleared for clinical use.
 
Event Description
It was reported that during a routine replacement of the safety disk by the customer, the cs300 intra-aortic balloon pump (iabp) generated a "low vacuum" alarm. There was no patient involvement and no adverse event was reported.
 
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Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
MDR Report Key8206830
MDR Text Key132215050
Report Number2249723-2018-02242
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2019
Is This a Reprocessed and Reused Single-Use Device? No

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