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

Model Number	WW1020
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 returned for investigation.Visual inspection noted the unit looks to be in used condition.Small scratches visible, no cracks.No accessories provided.Functional testing confirmed the complaint.Root cause was attributed to a faulty spo2 board; which was replaced.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Event or Problem Description
It was reported that the device is giving the error "18".The device came in for service and was found not to be working.There was no patient involvement and no adverse event/human harm.

• Brand Name: BCI HANDHELD OXIMETRY MONITOR, SPECTRO2
• 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: 19325984
• Report Number: 3012307300-2024-03749
• Device Sequence Number: 6615105
• Product Code: DQA
• UDI-Device Identifier: 30843418000375
• UDI-Public: (01)30843418000375(11)150316
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/15/2024

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 Model Number: WW1020
• Device Catalogue Number: WW1020A1EN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2015
• 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