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: CAREFUSION SD ALARIS SYSTEM; OXIMETER
  • 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
 

CAREFUSION SD ALARIS SYSTEM; OXIMETER Back to Search Results
Model Number 8210
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2021
Event Type  malfunction  
Manufacturer Narrative
The actual date of event is unknown.A review of the complaint history was performed which did not confirm similar complaints with the same or related failure mode.A review of the device history record was performed from the date of manufacture to the date of product release for distribution which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the service history record was performed which confirmed that this device was not involved in a service failure which correlates to the customer reported issue.Device evaluated by bd.
 
Event Description
It was reported that the device had a physical damage.There was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS SYSTEM
Type of Device
OXIMETER
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
brett wilko
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key12347611
MDR Text Key267440387
Report Number2016493-2021-58415
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10885403821011
UDI-Public(01)10885403821011
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022677
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8210
Device Catalogue Number8210 ALARIS SPO2 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-