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	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the device was showing error of "sr err".There was no patient involvement.
Additional Manufacturer Narrative
H6: codes were added.One device was returned for investigation.It was reported that the device was returned due to an sr error.Although this error can occur during normal operation, the unit was unable to connect to multiple finger sensors.A defective oximeter board was suspected and subsequently replaced.After replacement, the device successfully connects to the sensor and provides accurate readings.The device case was also found to be severely cracked and will be replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23007307
• Report Number: 3012307300-2025-10458
• Device Sequence Number: 18763037
• Product Code: DQA
• UDI-Device Identifier: 30843418000016
• UDI-Public: (01)30843418000016(11)120906
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2012
• 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