MAUDE Adverse Event Report: CAREFUSION SD ALARIS SPO2- MASIMO; OXIMETER

Model Number 8120

Device Problems Break (1069); Failure to Read Input Signal (1581)

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

Event Type  malfunction  

Manufacturer Narrative

A review of the complaint history record was performed for the sn (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.Based on the findings, service determined that the probable root cause of the reported issue was due to wear of the pca front cover.A review of the device history record showed the device had a manufacture date of 22nov2005.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(4) was performed 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 failed preventive maintenance.The dose cord connector is broken.No additional information was provided.There was no patient involvement.

• Brand Name: ALARIS SPO2- MASIMO
• 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: 11901366
• MDR Text Key: 254589789
• Report Number: 2016493-2021-506879
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403812002
• UDI-Public: 10885403812002
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2005
• 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-2719-2020
• Patient Sequence Number: 1