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U.S. Department of Health and Human Services

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

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DATASCOPE MAHWAH CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-0800-53
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2017
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date. A company service territory manager (stm) evaluated the iabp and was unable to duplicate the reported failure. The display demonstrated no evidence of failure. The iabp passed display and touchscreen tests. However, the stm did find physical damage to the blood pressure connector which prevented the blood pressure cable from being properly seated and registering a blood pressure reading on the display. The stm replaced the front end board in order to correct the damaged blood pressure connector. The stm completed preventive maintenance with full calibration, functional testing, and safety check to factory specifications. The iabp passed all functional and safety tests per factory specifications, returned to customer and cleared for clinical use.
 
Event Description
The customer reported that the display on the cardiosave malfunctioned. It is unknown when the event occurred. But no patient involvement or adverse event was reported.
 
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Brand NameCARDIOSAVE
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 Key7130412
MDR Text Key95805035
Report Number2249723-2017-01010
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112372
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 12/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2013
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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