MAUDE Adverse Event Report: WELCH ALLYN INC. VSM6800/SPM/ST/RADIO/PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number	68MXTX-B
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The connex vsm 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for noninvasive blood pressure (nibp).Pulse rate (pr).Noninvasive functional oxygen saturation of arteriolar hemoglobin (spo2).Body temperature in normal and axillary modes.The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.Monitoring can be accomplished on the vsm 6000 series bedside monitor itself, and the vsm 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.G., at a central station).Secondary remote viewing and alarming features are intended to supplement and not replace any patient bedside monitoring procedures.Upon inspection, the hrc technician determined that the power cord was burnt.The customer was provided with a replacement power cord.Although there was no reported injury with this event, overheating of the power cords were to recur, it could potentially cause serious injury or death.Therefore hillrom is reporting this event.
Event or Problem Description
The customer reported the power cord was bad.This event was captured under hillrom complaint ref # (b)(4).

• Brand Name: VSM6800/SPM/ST/RADIO/PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC.; 4341 state street east; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17377968
• Report Number: 1316463-2023-00166
• Device Sequence Number: 7214178
• Product Code: MHX
• UDI-Device Identifier: 00732094150933
• UDI-Public: 732094150933
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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: 68MXTX-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: 06/27/2023
• Initial Report FDA Received Date: 07/24/2023
• 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