MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC SURESIGNS VM 4 PATIENT MONITOR

Model Number 863063

Device Problem Fire (1245)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

The customer reported that their vm4 surgeons monitor caught fire due to a battery issue.There was no patient harm reported.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

Statement of the reported problem: this report is based on information provided by our philips contractor edmed in egypt and has been investigated by the philips complaint handling team.Philips received a complaint on the model vm4 sn (b)(6) indicating the unit caught on fire while plugged in and charging.The problem description reported the vital sign vm4 caught on fire because of battery, which philips recommend to replace after 3 years or 300 charging times.The device was not in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.There was no adverse event reported.Functional testing/service repair/technical investigation: visual inspection found: vm4 caught on fire while plugged in and charging.The maintenance supervisor (ms) went onsite to evaluate the devices in question.The technical investigation: based on the information provided by the maintenance supervisor (ms), the onsite visit 11/13/2022 revealed the battery was from 2016 and it was not previously replaced.The (ms) indicated the hospital had been notified by philips of fco86000256 on 7/21/2020 and in return the institution would inform philips of all devices stored in their database pending fco implementation.During the onsite visit, not all units were serviced for the fco, including the vm4 us42796680.Only five vm8 units received the fco86000256 software updates.Confirmation: based on the information available and the testing conducted fco86000256, the cause of the reported problem was confirmed.The reported problem was confirmed.Further action decision: based on the information available and results of additional analysis, no further action is necessary at this time.Risk analysis: a review of the risk management file was performed and initial reportability decision (based on information currently available) is that the record was determined to be reportable.It was reported the device presented with the following: the customer reported that their vital signs monitor caught fire due to an aged battery.A fire, explosion or breach of the device case has the potential to cause serious injury to patients, users and bystanders in the nearby area therefore this issue is reportable.Closure & product disposition: after the unit caught on fire, all units stored in the hospitals database pending fco implementation were updated.The fco will provide philips suresigns customers with software to assist with managing the monitors¿ battery state of health over its lifetime and including when to replace the battery.The customer has agreed to send back the unit for further analysis.

Manufacturer Narrative

This follow up report is in reference to manufacturing report 1218950-2022-01054.Additional information was received regarding the serial number of the battery that had caught fire.Sn - (b)(6).

Event Description

Statement of the reported problem: this report is based on information provided by our philips contractor edmed in egypt and has been investigated by the philips complaint handling team.Philips received a complaint on the model vm4 sn (b)(6) indicating the unit caught on fire while plugged in and charging.The problem description reported the vital sign vm4 caught on fire because of battery, which philips recommend to replace after 3 years or 300 charging times.The device was not in use monitoring a patient at the time of the event.No adverse event involving a patient or user was reported.There was no adverse event reported.Functional testing/service repair/technical investigation: visual inspection found: vm4 caught on fire while plugged in and charging.The maintenance supervisor (ms) went onsite to evaluate the devices in question.The technical investigation: based on the information provided by the maintenance supervisor (ms), the onsite visit (b)(6) 2022 revealed the battery was from 2016 and it was not previously replaced.The (ms) indicated the hospital had been notified by philips of (b)(4) on 7/21/2020 and in return the institution would inform philips of all devices stored in their database pending fco implementation.During the onsite visit, not all units were serviced for the fco, including the vm4 (b)(6).Only five vm8 units received the (b)(4) software updates.Confirmation: based on the information available and the testing conducted (b)(4), the cause of the reported problem was confirmed.The reported problem was confirmed.Further action decision: based on the information available and results of additional analysis, no further action is necessary at this time.Risk analysis: a review of the risk management file was performed and initial reportability decision (based on information currently available) is that the record was determined to be reportable.It was reported the device presented with the following: the customer reported that their vital signs monitor caught fire due to an aged battery.A fire, explosion or breach of the device case has the potential to cause serious injury to patients, users and bystanders in the nearby area therefore this issue is reportable.Closure & product disposition: after the unit caught on fire, all units stored in the hospitals database pending fco implementation were updated.The fco will provide philips suresigns customers with software to assist with managing the monitors¿ battery state of health over its lifetime and including when to replace the battery.The customer has agreed to send back the unit for further analysis.

• Brand Name: SURESIGNS VM 4 PATIENT MONITOR
• Type of Device: SURESIGNS VM 4 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16030141
• MDR Text Key: 305969767
• Report Number: 1218950-2022-01054
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K123900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: Health Professional
• Device Model Number: 863063
• Device Catalogue Number: 863063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 12/06/2022; 01/15/2023
• Supplement Dates FDA Received: 01/05/2023; 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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