MAUDE Adverse Event Report: WELCH ALLYN INC WIFI CSM,NIBP,MAS,RRP,BRAUNPRO6000,PLUG2; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	75RE-2
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A picture of the plug was provided by the customer where there was visible burns marks on the pin.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 7000-ps is the connex spot monitor 35 watt power supply.The customer refused to return the unit for inspection, therefore a root cause into the reported malfunction could not be confirmed.Although there was no injury reported, if the pin on cable were to burn off, it could cause or contribute to a death or serious injury if this were to recur.Therefore baxter is reporting this device malfunction.
Event or Problem Description
It was reported burn marks on cable pin.There was no reported injury.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: WIFI CSM,NIBP,MAS,RRP,BRAUNPRO6000,PLUG2
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: frances coote ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 21750482
• Report Number: 1316463-2025-00036
• Device Sequence Number: 18682385
• Product Code: MWI
• UDI-Device Identifier: 00732094335644
• UDI-Public: 732094335644
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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
• Device Model Number: 75RE-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/02/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown