MAUDE Adverse Event Report: WELCH ALLYN INC. WIFI,CSM,NIBP,MASIMO,SURETEMP,PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	75MT-B
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the power cord "smoked" when the csm unit was plugged into the power outlet and the unit would not take a bp reading.This event was captured under hillrom complaint ref # (b)(4).
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), respiration rate, and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.The most likely locations for patients to be monitored are general medical or surgical floors and general hospital and alternate care environments.The 7000-ps is the connex spot monitor 35 watt power supply.The device was returned for inspection where it was determined that there was burn marks on the power cord as a result of the apm overheating.It was additionally determined that the battery source was worn and the csb needed cleaning.For protection against shock, electrically powered welch allyn medical devices are designed, validated and manufactured per the isolation standards in "iec 60601-1".The standard is referenced in the instructions for use.This assures that the mains power is isolated to prevent injury to the patient and user from the mains electrical power.To prevent injury, there are warnings in the dfu including: warning do not perform troubleshooting on a device that is emitting smoke or exhibits other signs of excessive overheating.Disconnect the device from ac power and call welch allyn technical support immediately.Although the reported event did not result in a serious injury, the report of smoke from the device's power cable as a result of the power source overheating could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

• Brand Name: WIFI,CSM,NIBP,MASIMO,SURETEMP,PLUGB
• 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: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15378058
• Report Number: 1316463-2022-00127
• Device Sequence Number: 17591767
• Product Code: MWI
• UDI-Device Identifier: 00732094209372
• UDI-Public: 732094209372
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2022

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: 75MT-B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown