• 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 Displays Incorrect Message (2591); Device Sensing Problem (2917); Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2018
Event Type  malfunction  
Manufacturer Narrative
Full name of event site: (b)(6). (b)(4). The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date. As of the date of this report getinge service has not been requested. Additional information has been requested, and we will report accordingly if it becomes available.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed "ap optical sensing module failure" and at times no patient data was available. No patient harm, serious injury or adverse event was reported.
 
Manufacturer Narrative
A follow-up phone call was made to the customer to gather information regarding the status of the iabp unit. The customer reported that a preventative maintenance was performed on the iabp and no parts were replaced. The iabp unit was cleared and returned to clinical use.
 
Event Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) alarmed "ap optical sensing module failure" and at times no patient data was available. The customer called getinge for technical support. The getinge company representative walked the customer through the messages and the iabp was swapped for another. No patient harm, serious injury or adverse event was 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
MDR Report Key7690968
MDR Text Key114412938
Report Number2249723-2018-01195
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K063525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0998-00-3023-53
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received11/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

-
-