MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; OXIMETER

Model Number 8220

Device Problem Corroded (1131)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The actual date of event is unknown.A review of the complaint history for this serialized unit did not confirm similar complaints, based on the same or related failure mode for this event.A review of the device history record was performed from the date of manufacture to the date of product release for distribution which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.

Event Description

It was reported that the device had iui-corrosion(male-right).There was no patient involvement.

• Brand Name: ALARIS SYSTEM
• Type of Device: OXIMETER
• Manufacturer (Section D): 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: 12369380
• MDR Text Key: 268202890
• Report Number: 2016493-2021-58940
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403822018
• UDI-Public: (01)10885403822018
• 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
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8220
• Device Catalogue Number: 8220 ALARIS SPO2 MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2010
• 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