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

Catalog Number	WW1000EN
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was showing a sensor error message.There was no reported patient involvement.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.The device has not been returned to the manufacturer.
Additional Manufacturer Narrative
D3 - mfg establishment name and h6.Codes: updated.Device evaluation: unable to confirm the complaint due to the device not being returned.Based on the review of the service history and information provided by the customer we are unable to determine a probable cause as the device was not returned for evaluation.If the product is returned the manufacturer will re-open the complaint for further device analysis.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: BCI OXIMETER SPECTRO2 HANDHELD PATIENT MONITOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21942506
• Report Number: 3012307300-2025-05099
• Device Sequence Number: 18281194
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: (01)30843418000016(11)141121
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2014
• 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