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

Model Number 8210

Device Problems Circuit Failure (1089); Crack (1135); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This reported event and subsequent repairs were investigated through the service repair process.Failure data and parts-used information were reviewed for the sap and trackwise files and found relevant to the service repair.A review of the device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The database showed quality notifications were opened for the device with correlation to the reported complaint.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A trackwise complaint history review was completed, and it was confirmed that there were additional complaints received with similar sn (b)(4) for the same or related failure mode.Capa reference: ca-(b)(4).The customer stated that there was no patient involvement.

Event Description

(b)(4).Customer stated error 410.6030 was confirmed due to a bad display board of u7.Replaced it a new display board.Found cracked rear case at top for its wear, replaced it a new rear case assembly.(b)(4).

• 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
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: kasirajan mathirajan ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10808142
• MDR Text Key: 215328179
• Report Number: 2016493-2020-36020
• Device Sequence Number: 1
• Product Code: DQA
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• 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
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2006
• 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