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

Model Number 8220

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Manufacturer Narrative

The reported issue that the device had dim segment on the display could not be confirmed; no product or device logs were returned for investigation.No device history or qn search was performed since no source device serial number was reported by the customer.The alaris spo2 module is used for monitoring only.The file may be closed based on the above facts.The customer stated that there was no patient involvement.Customers received notification of the field action.The reported issue of a dim segment is confirmed based on the field action.Device repair or returns are handled within the scope of the field action.Device was not returned to manufacturing facility.

Event Description

(1) dim segment on led display spco2.Npr - no product returned.It was reported that the spco2 device dim segment on the led display is being replaced.Although requested here was no additional information provided by the customer at this time.

Event Description

(1) dim segment on led display spco2.Npr - no product returned.It was reported that the spco2 device dim segment on the led display is being replaced.Although requested here was no additional information provided by the customer at this time.

Manufacturer Narrative

The reported issue that the device had dim segment on the display could not be confirmed; no product or device logs were returned for investigation.No device history or qn search was performed since no source device serial number was reported by the customer.The alaris spo2 module is used for monitoring only.The file may be closed based on the above facts.The customer stated that there was no patient involvement.Customers received notification of the field action.The reported issue of a dim segment is confirmed based on the field action.Device repair or returns are handled within the scope of the field action.

• 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: 12007093
• MDR Text Key: 256475672
• Report Number: 2016493-2021-508378
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8220
• Device Catalogue Number: 8220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2826-2020
• Patient Sequence Number: 1