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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 Failure to Charge (1085); Low Battery (2584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2017
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 getinge standard operating procedure since the device manufacture date is greater than one year from the event date. A getinge service territory manager (stm) was dispatched to investigate. The stm evaluated the iabp and verified 0 charging voltage. The stm replaced the power management board and completed full function test. The iabp unit passed and was returned to clinical use.
 
Event Description
The customer reported that the cardiosave iabp unit emitted a low battery warning during transport. In addition, battery slot 2 was not charging the battery. The iabp continued to work fine. No patient information was available. 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 Key6882436
MDR Text Key87887095
Report Number2249723-2017-00506
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
Report Date 09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-0800-53
Device Lot NumberN/A
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 Received08/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2015
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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