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. - FAIRFIELD SENSATION 7FR. 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 CORP. - FAIRFIELD SENSATION 7FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0470-01
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 11/25/2020
Event Type  Death  
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.Complaint record id # (b)(4).
 
Event Description
It was reported that the customer stated the iabp was used on the patient for st segment elevation myocardial infarction (stemi).The customer stated that the pump was in auto mode with a pressure trigger.They did not have the ecg leads connected to the pump, thus ecg trigger was not available for use.The patient was asytole and they stopped chest compressions to check for a pulse.She said that the pump continued to pump in a pressure trigger.She asked why the pump would continue pumping if the patient was asystole and they were not providing chest compressions.Customer did not attribute to the intra-aortic balloon (iab) or iabp.There was no reported malfunction on the iab.A separate report will be submitted for the cardiosave iabp.
 
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.There was no reported malfunction.All the failure modes are addressed in the risk file.No labeling review can be completed as there was no reported malfunction.There were no crf/capa/scar/nmcr identified for "no reported malfunction".The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint #(b)(4).
 
Event Description
It was reported that the customer stated the iabp was used on the patient for st segment elevation myocardial infarction (stemi).The customer stated that the pump was in auto mode with a pressure trigger.They did not have the ecg leads connected to the pump, thus ecg trigger was not available for use.The patient was asytole and they stopped chest compressions to check for a pulse.She said that the pump continued to pump in a pressure trigger.She asked why the pump would continue pumping if the patient was asystole and they were not providing chest compressions.Customer did not attribute to the intra-aortic balloon (iab) or iabp.There was no reported malfunction on the iab.A separate report will be submitted for the cardiosave iabp.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SENSATION 7FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key11047831
MDR Text Key241254571
Report Number2248146-2020-00681
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106779
UDI-Public10607567106779
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 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/10/2023
Device Model Number0684-00-0470-01
Device Catalogue Number0684-00-0434
Device Lot Number3000114652
Was Device Available for Evaluation? No
Date Manufacturer Received12/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARDIOSAVE IABP
Patient Outcome(s) Death;
Patient Age65 YR
Patient Weight100
-
-