MAUDE Adverse Event Report: WELCH ALLYN, INC. CSM DESKTOP POWER SUPPLY; STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC

Model Number	7000-PS
Medical Device Problem Codes	Overheating of Device (1437); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The connex spot monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.Monitoring respiration rate from photophlethysmogram (masimo rrp) is indicated for adult and pediatric patients greater than two years old.The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.This product is available for sale only upon the order of a physician or licensed health care professional.The device was returned for inspection where it was determined that the power cord and power supply had burn damage.The power cord and power supply will be replaced for the customer.Although there was no reported injury with this event, if the report of burned device and spark were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.
Event or Problem Description
Customer reported the staff noticed the end of cable was burnt and smelt of burning.The device was then plugged back in to a different mains lead which then caused the machine at the connector to spark.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: CSM DESKTOP POWER SUPPLY
• Common Device Name: STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: mauricio cerecer ; 1069 state route 46 east; batesville, IN 47006
• MDR Report Key: 24328500
• Report Number: 1316463-2026-00009
• Device Sequence Number: 10041396
• Product Code: HMF
• UDI-Device Identifier: 00732094230598
• UDI-Public: (01)00732094230598
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: 7000-PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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