MAUDE Adverse Event Report: WELCH ALLYN INC VSM6400/SPN/ST/PLUG66; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 64NTXX-6

Device Problem Sparking (2595)

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

Event Date 10/26/2023

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) 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.Pwcd-b is the part # of the power cord used with the cvsm device.The unit was removed from service and returned to hillrom for investigation where the hrc technician inspected the unit thoroughly and found no problem with the device in relation to the reported sparking.There was a burn mark observed on the plug pin of the main power cable.Per the hrc technician, it is considered that the sparking was not cause by the device but was caused by an issue with the hospitals power socket.A replacement power cord was sent to the customer and they were advised to check the facilities power sockets.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 cord that sparked when plugged into an outlet were to recur, it could potentially cause serious injury or death.Therefore hillrom is reporting this event.

Event Description

The customer reported that the power cable sparked when connected to the power socket.There was no injury reported.This complaint was captured under hillrom ref # (b)(4).

• Brand Name: VSM6400/SPN/ST/PLUG66
• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN INC; 4341 state street; skaneateles falls NY
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18133352
• MDR Text Key: 328074255
• Report Number: 1316463-2023-00244
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094091182
• UDI-Public: 732094091182
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/14/2023

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: 64NTXX-6
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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