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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 Problems Calibration Problem (2890); Computer Operating System Problem (2898)
Patient Problem Death (1802)
Event Date 01/07/2017
Event Type  Death  
Event Description
Initially, the customer reported that the unit generated ""fiber optic sensor calibration postponed" and "unable to update timing" while in use on a patient. Additional information was provided to us by the customer advising that the patient had expired. The customer is not attributing the patient's death to the device.
 
Manufacturer Narrative
On (b)(6) 2017 03:45 pm (gmt-5:00) added by (b)(6) (b)(4): the production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted. A company service representative was dispatched to evaluate the unit and was unable to reproduce the reported malfunction. The representative completed full calibration, functionality, and safety checks per factory specifications, and returned the unit to the customer for clinical use. ***************************************************************************************** on (b)(6) 2017 10:45 am (gmt-5:00) added by (b)(6) (b)(4): the production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.
 
Event Description
Initially, the customer reported that the unit generated ""fiber optic sensor calibration postponed" and "unable to update timing" while in use on a patient. Additional information was provided to us by the customer advising that the patient had expired. The customer is not attributing the patient's death to the device.
 
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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 Key6301753
MDR Text Key104319433
Report Number2249723-2017-00004
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
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0998-00-0800-53
Other Device ID NumberCH212819F5
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 Received01/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/23/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/03/2017 Patient Sequence Number: 1
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