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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 Premature Discharge of Battery (1057); Loss of Power (1475); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The full name of the event site is (b)(6) hospital 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 field service engineer (fse) was dispatched to the customer site. The fse evaluated the iabp unit and was unable to reproduce the reported issue. The fse observed system and replaced the batteries as a precaution. The iabp unit passed all functional and safety tests per factory specifications. The iabp was then released to the customer and cleared for clinical service.
 
Event Description
It was reported that prior to use, the cs300 intra-aortic balloon pump (iabp) shutdown on the battery power. The battery status showed the batteries were fully charged. The customer later reported to the getinge representative stating that the iabp unit would run a short time on the batteries. No patient was involved 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
Manufacturer (Section G)
DATASCOPE MAHWAH
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
1300 macarthur blvd.
mahwah, NJ 07430
MDR Report Key7891398
MDR Text Key120973199
Report Number2249723-2018-01629
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 09/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/19/2018
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 Received08/31/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2007
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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