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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 Problems Corroded (1131); Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit is not required to be reviewed as per the company standard operating procedure since the device manufacture date is greater than one year from the event date. During a pm service, the getinge field service engineer (fse) evaluated the front-end board and noticed it would not calibrate. To fix the issue, the fse replaced front end board as per manufacturer specifications. The fse completed the pm and the unit passed all functional and safety tests per factory specifications. The iabp was then released to the customer for return to clinical service. The full name of the event site noted (b)(6) hospital.
 
Event Description
During a preventive maintenance (pm) performed by a getinge field service engineer (fse), the front-end board of the cs300 intra-aortic balloon pump (iabp) could not calibrate. The fse performed a transducer calibration and the front end board was not adjusting. The fse noticed that the front end board has corrosion damage from saline. No patient was involved during this event. 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
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7870105
MDR Text Key120245545
Report Number2249723-2018-01580
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
Reporter Occupation
Type of Report Initial
Report Date 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2018
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2005
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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