MAUDE Adverse Event Report: CAREFUSION SD 8220 ALARIS SPO2 - MASSIMO; PUMP, INFUSION

Model Number	8220 ALARIS SPO2 MODULE
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this event was inadvertently reported under incorrect product registration number (manufacturer report number 9616066-2021-00007).This mdr resubmission now reflects the correct product registration number.The customer reported problem was confirmed.A review of the device history record in sap for sn: (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn: (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.
Event or Problem Description
Error code 471.6211.Communication failure in spo2 board.On (b)(6) 2020 07:43:43 (b)(6).Shipping & billing addresses confirmed.There was no patient involvement.
Additional Manufacturer Narrative
Addition: updated adverse event codes (h6).
Event or Problem Description
(b)(4).

• Brand Name: 8220 ALARIS SPO2 - MASSIMO
• Common Device Name: 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 Key: 16046236
• Report Number: 2016493-2022-1179027
• Device Sequence Number: 6220460
• Product Code: DQA
• UDI-Device Identifier: 10885403822018
• UDI-Public: 10885403822018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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
• Operator of Device: Other
• Device Model Number: 8220 ALARIS SPO2 MODULE
• Device Catalogue Number: 8220 ALARIS SPO2 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown