MAUDE Adverse Event Report: WELCH ALLYN INC CONNEX VITAL SIGNS MONITOR 6000 SERIES; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 67NXXX-2

Device Problems Arcing (2583); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2024

Event Type  malfunction  

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) nr.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.The power cord was received by baxter.Upon inspection, it was determined that the power cord was damaged at power socket pins due to the electric arc.A replacement power supply was sent to the customer.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a power supply having an electric arcing were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

Event Description

The customer reported when attaching the power cord to the outlet, there was a loud sound and an electric arc.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: CONNEX VITAL SIGNS MONITOR 6000 SERIES
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY 13153
• Manufacturer Contact: daniela avila ; 4341 state street; skaneateles falls, NY 13153 ; 8129310130
• MDR Report Key: 19036999
• MDR Text Key: 339331745
• Report Number: 1316463-2024-00042
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094193275
• UDI-Public: 732094193275
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K171621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2024

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: 67NXXX-2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1