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

MAUDE Adverse Event Report: DATASCOPE CORP. - 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 CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0998-00-0800-53
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Manufacturer Narrative
A (b)(4) field service engineer (fse) was dispatched to investigate. The fse evaluated the iabp unit and discovered that the zero button was not missing, but rather had been pushed into the unit as a result of the metal bracket holding the button had been bent back. Although this was customer abuse and not covered by the contract, the fse resolved the issue by bending the bracket back to straight which allowed the button to be visible and function properly. The fse then performed functional and safety checks to meet factory specifications. The iabp was then released to the customer and cleared for clinical service. A supplemental report will be submitted when additional information is provided.
 
Event Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had the "zeroing" button missing. It is unknown the circumstances under which the event occurred. However, there was no patient involvement, and no adverse event 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 CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ
Manufacturer Contact
dorota wolpiuk
1300 macarthur blvd
mahwah, NJ 
MDR Report Key12023837
MDR Text Key258061413
Report Number2249723-2021-01287
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
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 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0998-00-0800-53
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?
Event Location No Information
Date Manufacturer Received05/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

-
-