MAUDE Adverse Event Report: CAREFUSION SD 8220 SPO2 MOD. (MASIMO); OXIMETER

Model Number 8220

Device Problems Device Alarm System (1012); Break (1069); Computer Software Problem (1112); Contamination (1120); Crack (1135); Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

The affected device has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

It was reported that there was an error code for incompatibility.No additional information.No patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they flashed device to v9.33 for error 400.5040.Replaced broken rear case and right iui.Replaced contaminated left iui.The failure code other was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.A review of the device history record showed the device had a manufacture date of 08apr2015.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Based on the findings, service determined that the proximate cause of the reported issue was due to device needs to be reflashed to v9.33 (error code 400.5040).A review of the complaint history record in trackwise and sap was performed for the (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that there was an error code for incompatibility.No additional information.No patient involvement.

• Brand Name: 8220 SPO2 MOD. (MASIMO)
• Type of Device: OXIMETER
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11477383
• MDR Text Key: 239611628
• Report Number: 2016493-2021-29970
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403822018
• UDI-Public: 10885403822018
• Combination Product (y/n): N
• PMA/PMN Number: K010966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2721-2020
• Patient Sequence Number: 1