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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8210 ALARIS SPO2 - NELLCOR; PUMP, INFUSION
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CAREFUSION SD 8210 ALARIS SPO2 - NELLCOR; PUMP, INFUSION Back to Search Results
Model Number 8210 ALARIS SPO2 MODULE
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
The information provided was obtained from a retrospective review of servicing data; therefore, no other information is obtainable at this time.There was no reported patient involvement.
 
Event Description
It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.
 
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Brand Name
8210 ALARIS SPO2 - NELLCOR
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
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 Key13151301
MDR Text Key289176756
Report Number2016493-2022-14622
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10885403821011
UDI-Public10885403821011
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8210 ALARIS SPO2 MODULE
Device Catalogue Number8210 ALARIS SPO2 MODULE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2006
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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