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 Insufficient Information (3190)

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

Event Date 05/25/2022

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 onsite technician tested the cvsm with a new power cord and it passed electrical safety testing.The device is now functioning as intended.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.

Event Description

It was reported that the cvsm unit caused the circuit breaker on ward to trip leaving the entire ward completely without power.Only emergency lighting and the ups on the central stations was left on.No patient injury was reported.This event 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: 14697114
• MDR Text Key: 294399614
• Report Number: 1316463-2022-00088
• 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
• Type of Report: Initial
• Report Date: 06/15/2022

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/15/2022
• 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