MAUDE Adverse Event Report: ICU Medical, Inc. BCI Spectro2 Pulse Oximeter

Catalog Number	WW1030EN
Medical Device Problem Codes	Fire (1245); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ac adapter caught fire and the plastic piece that goes into the bottom in the device melted.When the bci spectro2 pulse oximeter was connected to the ac adapter, the facility had noticed a burning smell followed by a plastic smell.The facility immediately investigated and observed that the connector was hot to touch, the plastic connector was melted and the metal at the connector was burnt.It burned the night stand too.There were patient involvement and no patient harm.
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: BCI Spectro2 Pulse Oximeter
• Common Device Name: Oximeter
• Manufacturer (Section D): ICU Medical, Inc.; 9124 polk ln, suite 101; olive branch MS 38654
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50241671
• Report Number: 3008818980-2026-00001
• Device Sequence Number: 10378806
• Product Code: DQA
• UDI-Device Identifier: 30843418000191
• UDI-Public: (01)30843418000191(11)130713
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• PMA/510(K) Number: K083557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: Other
• Device Catalogue Number: WW1030EN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 126 LB