• 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 Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted. A getinge service territory manager (stm) was dispatched to investigate and confirmed the reported issue and noted that the device was fully functional except for the battery operation. The stm reviewed the log files and found no electrical failure codes and verified batteries are not showing any data in the service menu. The stm replaced the power management board and made sure the harnesses were seated properly but the iabp unit still fails in battery mode. The stm returned the next day and replaced 2nd power management board, power supply assembly, executive processor board, backplane board, and front end board, but the iabp continued to fail with no battery function. The stm then investigated further and removed the power slot interface board and discovered saline residue under the power slot interface chassis and in between the chassis and the power slot interface board at the j4 connector. The stm reinstalled all original boards and cleaned and dried the saline residue out of the bottom of chassis. The stm noted there was no signs of saline that entered through the main unit. The stm then returned the next day and replaced the power slot interface board and reassembled the device for testing, but the iabp still remains operating on ac power only. The stm consulted with the customer and had the iabp unit brought to his office for further investigation and found that the j15 was not seated correctly. The stm repositioned, reseated and secured the j15 wire harness, and tested the device. The batteries were charging and the iabp unit was able to operate on the battery. The stm tested the iabp unit for a few hours without any further failures. The stm then performed all calibration, functional and safety tests per factory specifications and the iabp was returned to the customer and cleared for clinical service.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) was not recognizing the batteries, and was unable to detect the batteries in bay 1 and 2. It is unknown under which circumstances this event occurred; however, there was no patient involvement and 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 Key8191631
MDR Text Key131332099
Report Number2249723-2018-02208
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
Report Date 12/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-