• 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 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 MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0998-00-3023-53
Device Problems Device Inoperable (1663); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
This is considered an out of box failure of the cs300 power supply. Another power supply was installed into the cs300 and all operations worked. The failed power supply is being sent to the manufacturing facility for failure analysis. A production device history record (dhr) review is not required as this complaint is for an out-of-box part failure. (b)(6).
 
Event Description
It was reported that while performing a repair on a cs300 it was discovered that the new power supply being installed was defective. The cs300 would power up but the display would not function. There was no patient involvement or adverse event reported.
 
Manufacturer Narrative
A senior repair technician of the getinge national repair center (nrc) inspected the power supply and no visual damage was observed. The technician installed the power supply into cs300 test fixture. The part was tested to factory specifications per cs300 service manual. Testing failed and the technician verified the reported failure, ¿white screen on monitor display with the power switch off¿. The nrc technician sent the power supply to the supplier for failure analysis per procedure. A supplemental report will be submitted when additional information is made available.
 
Event Description
It was reported that while performing a repair on a cs300 it was discovered that the new power supply being installed was defective. The cs300 would power up but the display would not function. There was no patient involvement or adverse event reported.
 
Manufacturer Narrative
The supplier returned the power supply to the getinge national repair center (nrc) and verified the reported failure. They replaced the defective components, the power supply passed all of their testing and they updated the fan. A senior repair technician of the getinge nrc installed the power supply into a cs300 test fixture and tested to factory specifications per cs300 service manual. The technician inspected the power supply per procedure; it passed testing and was put into stock.
 
Event Description
It was reported that while performing a repair on a cs300 it was discovered that the new power supply being installed was defective. The cs300 would power up but the display would not function. There was no patient involvement or 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 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 Key7650584
MDR Text Key113004235
Report Number2249723-2018-01101
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-