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: LIVANOVA DEUTSCHLAND S5 CARDIOPLEGIA SENSOR MODULE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
  • 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
 

LIVANOVA DEUTSCHLAND S5 CARDIOPLEGIA SENSOR MODULE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 27-80-20
Device Problems Application Program Problem: Dose Calculation Error (1189); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 s5 cardioplegia sensor module.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
 
Event Description
Livanova (b)(4) received a report that a s5 cardioplegia sensor module displayed and calculated an incorrect value during procedure.There was no report of patient injury.
 
Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.As no malfunction could be detected the device was returned to the customer.
 
Event Description
See initial.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
S5 CARDIOPLEGIA SENSOR MODULE
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8137173
MDR Text Key129596201
Report Number9611109-2018-01375
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27-80-20
Was the Report Sent to FDA? No
Date Manufacturer Received01/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-