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 Problems Smoking (1585); Sparking (2595)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found that after the rcd alarm was reset, staff plugged in the monitor again and then electrical sparks and smoke were coming out of the power point.There was no patient/user injury reported.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 power cord was replaced and the customer performed an electrical safety test post-incident and the cvsm passed.No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hillrom received a report from a customer stating that initially the rcd alarm went off , when the cvsm monitor was plugged in.After the rcd alarm was reset, staff plugged in the monitor again and that is when the electrical sparks and smoke was coming out of the power point.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The hillrom technician found that after the rcd alarm was reset, staff plugged in the monitor again and then electrical sparks and smoke were coming out of the power point.There was no patient/user injury reported.After replacing the power cord the device successfully passed the electrical safety test.The power cord was returned to hillrom for further inspection.Hillrom was not able to identify the manufacturer of the power cord , however we were able to confirm it is not a hillrom power cord and the cvsm was functioning as designed.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 power cord was replaced with a hillrom power cord and the customer performed an electrical safety test post-incident and the cvsm passed.As the power cord is not manufactured by hillrom , no further investigation could be performed on the power cord.The hrc technician investigated the device thoroughly and could not replicate the reported issue.No malfunction.There was no serious incident reported and should this incident recur, it is unlikely to cause or contribute to a serious incident for the reasons stated above.Therefore, hillrom does not consider this complaint reportable.Based on this information no further action is required.

Event Description

Hillrom received a report from a customer stating that initially the rcd alarm went off , when the cvsm monitor was plugged in.After the rcd alarm was reset, staff plugged in the monitor again and that is when the electrical sparks and smoke was coming out of the power point.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (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
• MDR Report Key: 12345463
• MDR Text Key: 267367398
• Report Number: 1316463-2021-00033
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00732094192575
• UDI-Public: 732094192575
• Combination Product (y/n): N
• PMA/PMN Number: K171621
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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 Operator: No Information
• Device Model Number: 68NXTX-6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1