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	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the back housing was charred.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (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.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 and the pwcd-2 is the power cord.The complete device was received at hillrom service center.It was found that the device would not power on during functional check.The problem was found to be with the main board burnt.All welch allyn electrical devices are designed and tested to meet all applicable safety and flammability regulations.Welch allyn's vital signs, cardio and monitoring electrical devices are not held by the user and therefore decrease the likelihood that the user would sustain a 1st or 2nd degree burn if the device were to become hot.If these burns were to occur, they would generally not be considered serious and would heal without further medical intervention.Information regarding the safety and warnings specific to each device is in the instruction for use (ifu).As per the ifu, warning patient injury risk.Damaged cords, cables, and accessories can affect patient and operator safety.Never lift the monitor by the power supply cord or patient connections.Routinely inspect the ac power cord, blood pressure cuff, spo2 cable, and other accessories for strain relief wear, fraying, or other damage.Replace as necessary.The ifu also states as part of a caution to replace the power cord if the strain relief, cord insulation, or metal prongs are damaged or begin to separate from the attachment plug.Additionally, if a device were to get hot to touch, spark, have burn marks, melted or burned components a trained clinician would not use the device and remove it from the patient's environment.There was no reported patient involvement or injury in this complaint, however, as this event could potentially lead to a serious injury or death if it were to recur, hillrom considers this complaint reportable.Hillrom is supplying the customer with a loaner device.Based on this information, no further action is required.

• 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 NY 13153
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14252092
• Report Number: 1316463-2022-00056
• Device Sequence Number: 5015892
• Product Code: MWI
• UDI-Device Identifier: 00732094209372
• UDI-Public: 732094209372
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/29/2022
• 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