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

Model Number 8220

Device Problem Display Difficult to Read (1181)

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

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

It was reported that the customer is replacing the display.The customer stated that there was no patient involvement.

• 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: 12014696
• MDR Text Key: 256703398
• Report Number: 2016493-2021-508140
• 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: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• 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: 06/09/2021
• 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