MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; OXIMETER

Model Number 8210

Device Problem Insufficient Information (3190)

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

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.Initial reporter e-mail: unknown.The actual date of event is unknown.Bd technical support troubleshoot with customer over the phone.The reported issue that the spo2 unit wont power on was confirmed by tech support.¿ tech support had a walk through with the customer and revealed the following,¿ tech call in before with same issue on same spo2 unit will not power on completely dead.Tech was told to replace logic board tech replace logic board today and same is still will not power on.Next step to send unit in for services repair confirm level one quote for repair, tech will call back once po# is setup for the amount.High level steps/procedure: plug the instrument into ac.Check and/or replace the battery.Check the fuses.Replace the off-line switcher.Replace the power supply board.Return the module to the factory.No further investigation of this issue is possible at this time, and no patient involvement was reported.Based on troubleshooting results, technical services couldn¿t determine the probable cause of the customer¿s reported issue.Device was not returned to manufacturing facility.

Event Description

It was reported that the spo2 unit wont power on.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: 12058209
• MDR Text Key: 258065841
• Report Number: 2016493-2021-54729
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403821011
• UDI-Public: (01)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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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 ALARIS SPO2 MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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