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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
Model Number N/A
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/30/2018
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 company standard operating procedure since the device manufacture date is greater than one year from the event date. A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had an electrical safety test failure. It is unknown under which circumstances this event occurred or if a patient was involved. However, no adverse event was reported.
 
Manufacturer Narrative
Please note, the date of the initial emdr should have been reported as (b)(6) 2018. The initial reporter named is a getinge employee whose contact information is: email address (b)(6); which differs from that of the event site. A getinge fse evaluated the iabp unit and replaced the power cord reel. The iabp unit passed the power cord resistance to specifications. The pm was completed and the iabp passed all functional and safety tests to factory specifications. The unit was returned to the customer and cleared for clinical use.
 
Event Description
While performing a preventative maintenance (pm), the getinge field service engineer (fse) discovered that the cardiosave intra-aortic balloon pump (iabp) failed the electrical safety test with a resistance above specifications. There was no patient involvement and no 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 Key7627154
MDR Text Key112453722
Report Number2249723-2018-01050
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,Followup
Report Date 07/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
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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