MAUDE Adverse Event Report: WELCH ALLYN INC. VSM6800/SPN/ST/RADIO/PLUG66; MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 68NXTX-6

Device Problem Sparking (2595)

Patient Problem Electric Shock (2554)

Event Date 05/09/2022

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.The customer has not returned the device, therefore no further investigation into the root cause of the reported issue could be performed.Should additional information be provided, a supplemental report will be filed.However, based on the information provided at this time no further action is required.Hillrom is cautiously reporting this event.

Event Description

It was reported a staff member received electric shock/burn when plugging in the observation machine.The observation machine had a flat battery and the machine was plugged into the bedside wall socket.The power point was flicked to the ¿on¿ position and a loud pop/fizzing sound was heard with a spark seen.The staff member¿s left hand thumb received slight burn and shock.The patient outcome resulted in injury/illness and was identified as electrical shock on the back and front of the left thumb.The staff member required first aid care and went to the gp to undertake an ecg.This event has been captured under hillrom complaint ref # (b)(4).

• Brand Name: VSM6800/SPN/ST/RADIO/PLUG66
• 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: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14712933
• MDR Text Key: 294519354
• Report Number: 1316463-2022-00089
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094192575
• UDI-Public: 732094192575
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2022

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: 68NXTX-6
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1