• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problems Leak/Splash (1354); Computer Operating System Problem (2898)
Patient Problem No Patient Involvement (2645)
Event Date 11/08/2018
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. Upon further inspection by the getinge stm, the only fluid intrusion that was found was on top of the printer recorder which caused electrical damage to the recorder. To resolve the issue, the stm replaced the printer and the recorder and the iabp was able to print. The stm then completed the pm and performed all safety, electrical and functional tests to meet factory specifications. The initial reporter named is a getinge employee who has different contact details from that of the event site. Please refer to the following email and phone number: (b)(6).
 
Event Description
During preventive maintenance (pm) service of cardiosave intra-aortic balloon pump (iabp), the getinge service territory manager (stm) discovered the recorder failed to print. Additionally, the stm observed evidence of a saline spill on the front of the iabp. There was no patient involvement, thus no adverse event was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARDIOSAVE HYBRID TYPE B PLUG
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 Key8111916
MDR Text Key128888440
Report Number2249723-2018-02074
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
Reporter Occupation
Type of Report Initial
Report Date 11/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-