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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SPO2; OXIMETER

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CAREFUSION SD ALARIS SPO2; OXIMETER Back to Search Results
Model Number 8220
Device Problems Break (1069); Contamination (1120); Corroded (1131); Crack (1135); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.
 
Event Description
It was reported that the device had a broken case.No additional information was provided.There was no patient involvement.
 
Manufacturer Narrative
Additional information added to: e2, g2 for biomed as health professional.Update d8 for 3rd party servicer.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced broken rear case, front case and right iui.Replaced contaminated patient connector pcb and left iui.Replaced lifted keypad.The failure code othe was used to track the alaris 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.Based on the findings, service determined that the probable cause of the reported issue was due to damaged/cracked of the case rear unshielded.A review of the device history record showed the device had a manufacture date of 27jul2012.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(6) did not confirm similar complaints with the same or related failure mode for this customer.
 
Event Description
It was reported that the device had a broken case.No additional information was provided.There was 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 replaced broken rear case,front case and right iui.Replaced contaminated patient connector pcb and left iui.Replaced lifted keypad.The failure code othe was used to track the alaris 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 27jul2012.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 sn (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 probable cause of the reported issue was due to damaged/cracked of the case rear unshielded.A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
 
Event Description
It was reported that the device had a broken case.No additional information was provided.There was no patient involvement.
 
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Brand Name
ALARIS SPO2
Type of Device
OXIMETER
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11531347
MDR Text Key241823585
Report Number2016493-2021-31345
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,Followup
Report Date 02/15/2021
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 Manufacturer02/24/2021
Initial Date Manufacturer Received 03/05/2021
Initial Date FDA Received03/19/2021
Supplement Dates Manufacturer Received04/30/2021
04/30/2021
Supplement Dates FDA Received05/13/2021
05/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2721-2020
Patient Sequence Number1
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