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 05/04/2022

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.

Event Description

The customer reported that the drug room had an electrical short.Upon inspection the cvsm unit had a blackened pin plugged into the mains this event has been captured in hill-rom's complaint handling system under 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 road; skaneateles falls NY 13153
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14591699
• MDR Text Key: 294399403
• Report Number: 1316463-2022-00086
• 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: 06/03/2022

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: 05/04/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1