MAUDE Adverse Event Report: CAREFUSION SD 8210 ALARIS SPO2 - NELLCOR; PUMP, INFUSION

Model Number 8210 ALARIS SPO2 MODULE

Device Problem Corroded (1131)

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

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

The information provided was obtained from a retrospective review of servicing data; therefore, no other information is obtainable at this time.There was no reported patient involvement.

Event Description

It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.

Event Description

It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.

Manufacturer Narrative

The information provided was obtained from a retrospective review of servicing data; therefore, no other information is obtainable at this time.There was no reported patient involvement.

Event Description

It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event.There was no reported patient involvement.

Manufacturer Narrative

The information provided was obtained from a retrospective review of servicing data; therefore, no other information is obtainable at this time.There was no reported patient involvement.

• Brand Name: 8210 ALARIS SPO2 - NELLCOR
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 12560593
• MDR Text Key: 274225714
• Report Number: 2016493-2021-522616
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 10885403821011
• UDI-Public: 10885403821011
• Combination Product (y/n): N
• PMA/PMN Number: K022677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8210 ALARIS SPO2 MODULE
• Device Catalogue Number: 8210 ALARIS SPO2 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2722-2020
• Patient Sequence Number: 1