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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD 8220 SPO2 MOD. (MASIMO); OXIMETER

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CAREFUSION SD 8220 SPO2 MOD. (MASIMO); OXIMETER Back to Search Results
Model Number 8220
Device Problems Device Alarm System (1012); Break (1069); Computer Software Problem (1112); Contamination (1120); Crack (1135); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The affected device has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that there was an error code for incompatibility.No additional information.No patient involvement.
 
Manufacturer Narrative
This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they flashed device to v9.33 for error 400.5040.Replaced broken rear case and right iui.Replaced contaminated left iui.The failure code other was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.A review of the device history record showed the device had a manufacture date of 08apr2015.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Based on the findings, service determined that the proximate cause of the reported issue was due to device needs to be reflashed to v9.33 (error code 400.5040).A review of the complaint history record in trackwise and sap was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
 
Event Description
It was reported that there was an error code for incompatibility.No additional information.No patient involvement.
 
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Brand Name
8220 SPO2 MOD. (MASIMO)
Type of Device
OXIMETER
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11477383
MDR Text Key239611628
Report Number2016493-2021-29970
Device Sequence Number1
Product Code DQA
UDI-Device Identifier10885403822018
UDI-Public10885403822018
Combination Product (y/n)N
PMA/PMN Number
K010966
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8220
Device Catalogue Number8220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2021
Initial Date Manufacturer Received 02/17/2021
Initial Date FDA Received03/12/2021
Supplement Dates Manufacturer Received03/30/2021
Supplement Dates FDA Received05/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2721-2020
Patient Sequence Number1
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