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

Model Number 8220 ALARIS SPO2 MODULE

Device Problems Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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.

Manufacturer Narrative

Addition: updated adverse event codes (h6).

Event Description

(b)(4).

• Brand Name: 8220 ALARIS SPO2 - MASSIMO
• 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 Key: 16046236
• MDR Text Key: 308448292
• Report Number: 2016493-2022-1179027
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 12/26/2022
• Supplement Dates Manufacturer Received: 06/03/2020
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1