• 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 CS300 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 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number N/A
Device Problem Power Problem (3010)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2021
Event Type  malfunction  
Manufacturer Narrative
A getinge authorized dealer's field service engineer (fse) evaluated the iabp unit and was able to confirm the reported issue. To fix the issue, the fse replaced the power supply and 5000 hours maintenance package. The fse then turned on the iabp and confirmed that the power supply of the iabp was working normally (battery charging and discharging and ac power). Additional information is being requested with regard to the status of the iabp. A supplemental report will be submitted when this information is provided to us.
 
Event Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had power supply issues. It is unknown the circumstances under which the event occurred. It is also unknown if there was patient involvement. However, there was no adverse event reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCS300
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer (Section G)
DATASCOPE CORP. - MAHWAH
1300 macarthur blvd
mahwah NJ 07430
Manufacturer Contact
brian schaeffer
1300 macarthur blvd
mahwah, NJ 07430
MDR Report Key11297065
MDR Text Key230988548
Report Number2249723-2021-00227
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-