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 Unintended Electrical Shock (4018)

Patient Problem Shock (2072)

Event Date 12/03/2023

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 mode.The device was inspected and the lead itself was in good condition; however, there were signs of cracking in the molded plastic of the iec end of the lead.Physical damage was noted to the plastic molding of the plug below the earth pin, and charring was evident on the earth and active pins on the end of the power lead.The neutral pin was slightly bent out of alignment.The device and power lead as supplied, passed electrical safety testing.An electrical contractor attended to the gpo that was in use at the time of the incident and the gpo was replaced.Although it was reported that the user of the cvsm device received a shock to their fingers, the customer indicated there was no injury to the user and there was no report of medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, concluding a serious injury did not occur.If the reported problem (shock/signs of charring) were to recur, it would be likely to cause or contribute to a death or serious injury.

Event Description

It was reported that when the user plugged in the cvsm 6800 to the power socket, it made a ¿noise bang¿ and zapped the user¿s fingers.Per the customer, there was no injury associated with this event.This incident was 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: 18446519
• MDR Text Key: 332142923
• Report Number: 1316463-2024-00001
• Device Sequence Number: 1
• Product Code: MHX
• 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,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/04/2024

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: 68NXTX-6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/04/2024
• 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