MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BCI OXIMETER SPECTRO2 HANDHELD PATIENT MONITOR

Catalog Number	WW1000EN
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.Device evaluation: one device was received.Per visual inspection, no impact or corrosion damage present.Functional testing confirmed/replicated the complaint.Error 17 message displayed on startup.The cause was a faulty main board.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced the main board.Monitor passed all functional testing after repair.
Event or Problem Description
It was reported that the device was showing the error-17 before infusion.There was no patient involvement and no patient harm/adverse event reported.

• Brand Name: BCI OXIMETER SPECTRO2 HANDHELD PATIENT MONITOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19265055
• Report Number: 3012307300-2024-03477
• Device Sequence Number: 6968574
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: (01)30843418000016(11)200509
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: WW1000EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown