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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 Failure to Calibrate (2440)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
During preventive maintenance (pm) by the company service representative it was found that the pressure regulator would not calibrate. No patient involvement or adverse event reported.
 
Manufacturer Narrative
09/14/2017 02:08 pm (gmt-4:00) added by (b)(6) (pid-(b)(4)): on 24 aug 2017 the service territory manager confirmed that the correct aware date of the parent record is 12 june 2017. Corrected: (parent) aware date.
 
Event Description
During preventive maintenance (pm) by the company service representative it was found that the pressure regulator would not calibrate. No patient involvement or adverse event reported.
 
Manufacturer Narrative
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. The company service representative disassembled the iabp, replaced the drive pressure regulator and completed all the functional checkout procedures. The iabp was cleared for clinical use and returned to the customer.
 
Event Description
During preventive maintenance (pm) by the company service representative it was found that the pressure regulator would not calibrate. No patient involvement or adverse event 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 Key6708358
MDR Text Key104045737
Report Number2249723-2017-00085
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,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received06/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
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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