MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION WIFI CSM NIBP; Monitor, physiological, patient (without arrhythmia detection or alarms)

Model Number	901058
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that a connex spot monitor that was charging in a wall socket located high on the wall first began making crackling noises and then started emitting smoke.They unplugged the device from the wall socket.A small hole had already burned into the device's power cord.All devices connected to the same socket were unplugged.The smoking stopped.The process step during which this occurred was unknown.The reporter did not know if there was any patient injury or death associated with this event.
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• Brand Name: WIFI CSM NIBP
• Common Device Name: Monitor, physiological, patient (without arrhythmia detection or alarms)
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): WELCH ALLYN PRODUCTS, SKANEATELES; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50864166
• Report Number: 1316463-2026-00347
• Device Sequence Number: 13117960
• Product Code: MWI
• UDI-Device Identifier: 00732094335644
• UDI-Public: (01)00732094335644
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Device Model Number: 901058
• Device Catalogue Number: 75RE-2
• Device Lot Number: N/A
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown