MAUDE Adverse Event Report: CAREFUSION SD ALARIS SPO2; OXIMETER

Model Number 8210

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.Device repair or returns are handled within the scope of the field action.No further information will be provided by the customers due to the field action.Device not available for evaluation.

Event Description

It was reported that an 8120 spo2 display board was replaced because of the field action recall.There was no reported patient involvement.

• Brand Name: ALARIS SPO2
• Type of Device: OXIMETER
• 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: 12552731
• MDR Text Key: 274004447
• Report Number: 2016493-2021-522153
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403821011
• UDI-Public: 10885403821011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022677
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8210
• Device Catalogue Number: 8210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2007
• 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