Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. CS300; INTRA-AORTIC BALLOON PUMP
  • 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. CS300; INTRA-AORTIC BALLOON PUMP Back to Search Results
Model Number CS300
Device Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2013
Event Type  malfunction  
Event Description
At the completion of a pm and safety check, the company rep observed smoke coming from the iabp power supply and the odor of burning electronics/electrical components.
 
Manufacturer Narrative
The company rep replaced the power supply (part number 0014-00-0033e05).The iabp was tested to factory spec.It functioned normally and was returned to the customer.The company rep returned and replaced power supply to the mfr and the mfr eval confirmed the failure as a shorted cr38.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CS300
Type of Device
INTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
DATASCOPE CORP.
mahwah NJ
Manufacturer (Section G)
DATASCOPE CORPORATION
1300 macarthur blvd.
mahwah NJ 07430
Manufacturer Contact
tina evancho
45 barbour pound drive
wayne, NJ 07470
9737097690
MDR Report Key3871956
MDR Text Key4568700
Report Number2249723-2014-00420
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Unknown
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 10/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCS300
Device Catalogue Number0998-00-3023-XX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/23/2013
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-