• 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 Backflow (1064)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2023
Event Type  malfunction  
Event Description
It was reported that during a service repair by a getinge field service engineer, the cardiosave intra-aortic balloon pump (iabp) was found to have old dried blood in the pim and safety disk.There was no patient involvement.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
 
Manufacturer Narrative
The getinge field service engineer (fse) that encountered the reported issue during during repair of pump and found old dried blood in the pim and safety disk.Replaced all blood contaminated parts.Performed a full functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CARDIOSAVE HYBRID, TYPE B PLUG
Type of Device
SYSTEM, 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
arelean guzman
1300 macarthur blvd
mahwah, NJ 
MDR Report Key16772109
MDR Text Key313746224
Report Number2249723-2023-01990
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567108391
UDI-Public10607567108391
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 Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/07/2023
Initial Date FDA Received04/19/2023
Supplement Dates Manufacturer Received01/31/2024
Supplement Dates FDA Received01/31/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-