MAUDE Adverse Event Report: WELCH ALLYN INC SPOT 4400 W NIBP SURETEMP NONIN PLUG B; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	44WT-B
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a nurse received an electrical shock when disconnecting the power cable of a spot 4400 from the wall outlet.This event was captured under hill-rom complaint ref # (b)(4).
Additional Manufacturer Narrative
The welch allyn spot vital signs 4400 (device) is intended to be used by clinicians and medically qualified personnel for operator initiated spot-check/single measurement of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2), and body temperature in oral, rectal and axillary modes of adult and pediatric patients down to 29 days of age.The intended use locations for patients to be measured are physician¿s offices, general hospital, and alternate care environments.The device ifu notes the following warnings regarding damage to the device: (1) patient injury risk.Damaged cords, cables, and accessories can affect patient and operator safety.Never lift the device 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.(2) never move the device or mobile stand by pulling on any of the cords.This may cause the device to tip over or damage the cord.Never pull on the power cord when disconnecting the cord from the mains outlet.When disconnecting the power cord, always grasp the attachment plug.Keep the cord away from liquids, heat, and sharp edges.Replace the power cord if the strain relief, cord insulation, or metal prongs are damaged or begin to separate from the attachment plug.The device ifu additionally recommends the following regarding maintenance and service checks: (1) update settings, replace items, or call for service as necessary, based on results from a visual inspection.Do not use the device if you see any signs of damage.Qualified service personnel must check any device that is damaged for proper operation before putting the device back into operation.(2) visually inspect the following at least weekly: all cables, cords, and connector ends for damage or contamination.The pwcd-b is the connex spot monitor north american power cord.It was noted by the customer that there was a cut in the device cable from an unknown source.Post the event, the nurse had, ¿shakes¿ and a headache that lasted approximately 24 hours.The nurse was evaluated and cleared by a physician.No time off work was required, and the customer states the nurse has no residual effects.The customer sent the device and its components back to hillrom for evaluation.Inspection of the device by a hillrom technician noted the ¿hot side prong on power cable plug is burned and chipped.¿ it was additionally determined that the battery connector on the pcba was cracked and the battery cover screw was pushed in on the rear housing.The nurse received an electrical shock with no allegation of injury or medical intervention required.Procedures for prevention of this type of event are outlined in the device user manual as noted above.Pain / discomfort may be a symptom due to preexisting injury contained to a discrete area or a symptom felt more diffusely due to disorder or disease; however, pain/discomfort is not an injury of itself.Pain/discomfort is an unpleasant sensation that typically stops once the stimulus is removed, is not life-threatening and does not require medical or surgical intervention to preclude permanent impairment of a body function or body structure.The user experienced transient, minor discomfort that was not life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure and there was no need for medical or surgical intervention.A damaged cord or plug can lead to transfer of electric current from the device to the user resulting in electrical shock and is likely to result in serious injury or death with recurrence.Hill-rom is cautiously reporting this event.

• Brand Name: SPOT 4400 W NIBP SURETEMP NONIN PLUG B
• 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: 15535209
• Report Number: 1316463-2022-00141
• Device Sequence Number: 20155053
• Product Code: MWI
• UDI-Device Identifier: 00732094309409
• UDI-Public: 732094309409
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: 44WT-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: 09/19/2022
• Initial Report FDA Received Date: 10/04/2022
• 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