MAUDE Adverse Event Report: WELCH ALLYN, INC VSM6500/SPN/ST/RADIO/PLUGB; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Model Number	65NTXX-B
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hillrom technician found the cvsm 6500 caught on fire.The connex vital signs monitor is an intuitive, touchscreen monitor featuring bright, vivid colors for improved workflows and training.Adaptable for most low-acuity healthcare environments and clinical workflows, it can measure pulse oximetry, noninvasive blood pressure, temperature, etco2, respiration and more.Multiple profiles support spot check vitals, averaging, intervals and continuous monitoring workflows.Help prevent patient deterioration using optional early warning scores.With wireless emr connectivity, the cvsm sends vital information where your clinicians need it, when they need it.The device was received at hillrom service centre on 24-jun-2021 where it will be preliminarily inspected.The device will be then forwarded to the hillrom manufacturer for a thorough investigation.Hillrom will submit a final report with investigation conclusion on this incident.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 or Problem Description
Welch allyn received a report from ahillrom technician stating the cvsm 6500 caught on fire.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).
Event or Problem Description
Welch allyn received a report from a hillrom technician stating the cvsm 6500 caught on fire.The device was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).
Additional Manufacturer Narrative
The hillrom technician found the cvsm 6500 caught on fire.The connex vital signs monitor is an intuitive, touchscreen monitor featuring bright, vivid colors for improved workflows and training.Adaptable for most low-acuity healthcare environments and clinical workflows, it can measure pulse oximetry, noninvasive blood pressure, temperature, etco2, respiration and more.Multiple profiles support spot check vitals, averaging,intervals and continuous monitoring workflows.Help prevent patient deterioration using optional early warning scores.With wireless emr connectivity, the cvsm sends vital information where your clinicians need it, when they need it.The cvsm device was returned to welch allyn for investigation.The evaluation and investigation indicated that the root cause was an internal failure of the lithium ion battery.This failure caused a thermal runaway of the lithium ion battery that eventually resulted in a fire.Further root cause analysis of the battery pack will be completed by the battery manufacturer.Further testing of the csm device indicated that the csm was functioning as intended during the events that lead to the eventual failure.The pmp ate tests databases were checked for the serial number 103001751714.The results, indicate all tests passed.The investigation shows that the the lithium ion battery pack, batt99, failed and was the cause of the fire.Welch allyn has notified the battery manufacturer of the event and has issued a corrective action request to the supplier.This is the first occurrence of this failure.Welch allyn will continue to monitor complaint trends for this type of alleged malfunction.Based on this information, no further action is required.

• Brand Name: VSM6500/SPN/ST/RADIO/PLUGB
• Common Device Name: MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): WELCH ALLYN, INC; 4341 state street road; skaneateles falls NY 13153
• MDR Report Key: 12169698
• Report Number: 1316463-2021-00025
• Device Sequence Number: 3820109
• Product Code: MWI
• UDI-Device Identifier: 00732094088151
• UDI-Public: 732094088151
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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
• Operator of Device: No Information
• Device Model Number: 65NTXX-B
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1