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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; OXIMETER
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CAREFUSION SD ALARIS SYSTEM; OXIMETER Back to Search Results
Model Number 8220
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
Event Type  malfunction  
Event Description
It was reported that the device displayed an error code 471.6211 and also had channel error during preventive maintenance.There was no patient involvement.
 
Manufacturer Narrative
A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in this mdr report.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
 
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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 Key15071189
MDR Text Key304187210
Report Number2016493-2022-165286
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10885403822018
UDI-Public(01)10885403822018
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010966
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number8220
Device Catalogue Number8220 ALARIS SPO2 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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