• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; 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 FAIRFIELD TRANS-RAY PLUS 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0605
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Myocardial Infarction (1969)
Event Date 01/27/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient, it was noted that waveform was more spiky than usual.The customer obtained arterial pressure from transducer to continue procedure.An alarm was generated, but the alarm type is unknown.No patient injury was reported.
 
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient, it was noted that waveform was more spiky than usual.The customer obtained arterial pressure from transducer to continue procedure.An alarm was generated, but the alarm type is unknown.No patient injury was reported.
 
Event Description
It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient, it was noted that waveform was more spiky than usual.The customer obtained arterial pressure from transducer to continue procedure.An alarm was generated, but the alarm type is unknown.No patient injury was reported.
 
Manufacturer Narrative
The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter but it was not a maquet product.No blood was observed inside the iab catheter.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A sensor output test was performed and the sensor was found to be within specification.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported events cannot be confirmed by the evaluation.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRANS-RAY PLUS 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8355648
MDR Text Key136756460
Report Number2248146-2019-00108
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 04/02/2019
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 Health Professional
Device Expiration Date08/13/2021
Device Catalogue Number0684-00-0605
Device Lot Number3000078603
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2019
Device Age YR
Initial Date Manufacturer Received 01/28/2019
Initial Date FDA Received02/20/2019
Supplement Dates Manufacturer Received02/25/2019
03/28/2019
Supplement Dates FDA Received03/19/2019
04/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-