MAUDE Adverse Event Report: CAREFUSION SD 8220 ALARIS SPO2 - MASSIMO; PUMP, INFUSION

Model Number 8220

Device Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This reported event and subsequent repairs were investigated through the tsc troubleshooting process.A review of the device service history record was not performed because the serial number was not provided for the suspect device.A dhr (device history record) review cannot be completed as the serial number was not obtained upon receipt of the complaint.Additionally, a historical review of complaints in trackwise cannot be conducted.The customer stated that there was no patient involvement.

Event Description

(b)(4).Case description: biomed accidently removed unit from the 8015 while it was updating during pm.Received the 13-4-871 error when trying to reattach to 8015.Failure device type: alaris system instrument.Failure problem type: 8200.Failure mode: troubleshooting/ error codes.Case resolution: recommend to reflash software.If flashing fails or error does not go away, the logic board must be replaced.Biomed will try to flash unit.If fails will send in unit for repair.

• Brand Name: 8220 ALARIS SPO2 - MASSIMO
• Type of Device: PUMP, INFUSION
• 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: muthuswamy venkatasubramani ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10972962
• MDR Text Key: 230935136
• Report Number: 2016493-2020-60909
• Device Sequence Number: 1
• Product Code: DQA
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• 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
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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