MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VS4 NBP, SPO2

Model Number 863283

Device Problems Continuous Firing (1123); Insufficient Information (3190)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that the device caught on fire.The device was not in use on a patient at the time of the event.

Manufacturer Narrative

This supplemental report is created with reference to mfg report #1218950-2022-00265 with corrected information to update the registered legal manufacturing site.

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.H3 other text : further evaluation pending.

Event Description

According to philips records the battery field change order ((b)(4)) has been applied to the vs4 in question.This means that it is running the software with enhanced battery management.The unit was likely purchased 8 years ago (2016) when the medical facility was built.It is unknown whether the unit was new (through philips distribution) or used (through a 3-rd party) as, according to the fca, purchasing records were not available from the medical facility.Records about the battery (origin/purchase/maintenance) were also not available.We are not able to determine the age of the batteries being used.No problems with the unit were noted prior to this incident.At around 10pm the night before the incident the unit was plugged in for charging with the ac cord presumably vertically wrapped around the unit, which is standard practice.At around 5am the fire alarm sounded.When the fire brigade arrived the fire was already put off by the sprinklers.Philips was not invited to a site inspection where the damages occurred.A destructive examination of the phillips unit took place on (b)(6) 2022, at the fire cause analysis facility located (b)(6).The examination was supervised on behalf of (b)(6) insurance company.A representative of the customer was not there so we could not ask day-to-day operational questions such as whether they followed the battery maintenance guidelines.Fca had asked for service records but (b)(6) denied having any.The monitor was melted.Power cord and other cables (not readily identifiable) were also melted.We were not able to discover the mylar label with the serial number.We were able to locate the power inlet but not the fuses.No visible fire damage was observed on the ac power plug and the first couple of feet of the power cord or (from photos) on the ac outlet in the facility.We inspected the monitor/roll stand interface which seemed to have the proper screws.Main board covered with residue and we did not attempt to isolate it.An inspection of the battery compartment indicated that metal frame of the battery case was ¿intact¿ but that melted material from the monitor prevented access to the battery itself.X-ray examination showed damage to at least one battery cell and also a tiny ¿bulge¿ of the metal frame surrounding the battery in the location of the positive terminal of this cell in question.A consensus decision was reached to not disassemble further to avoid further damaging the battery.A cat scan was performed to retrieve any identification information on the battery, but results of the cat scan have not been provided to philips.

Event Description

The customer reported that the device caught on fire.No one was injured but the monitor was destroyed and there was some property damage.

Manufacturer Narrative

At around 10pm the night before the incident the unit was plugged in for charging with the ac cord presumably vertically wrapped around the unit, which is standard practice.At around 5am the fire alarm sounded.When the fire brigade arrived the fire was already put off by the sprinklers.Philips was not invited to a site inspection where the damages occurred.A destructive examination of the phillips unit took place on (b)(6) 2022, at the fire cause analysis (fca) facility.The examination was supervised by a representative on behalf of scvmc¿s insurance company.A representative of the customer was not there so philips could not ask day-to-day operational questions such as whether they followed the battery maintenance guidelines.Fca asked for service records but scvmc denied having any.Evaluation of the device by the fca determined the monitor was melted.The power cord and other cables (not readily identifiable) were also melted.The fca was not able to discover the mylar label with the serial number.The power inlet was located, but not the fuses.No visible fire damage was observed on the ac power plug and the first couple of feet of the power cord or (from photos) on the ac outlet in the facility.The monitor/roll stand interface was inspected and it used the proper screws.The main board was covered with residue and was not attempted to be isolated.An inspection of the battery compartment indicated that the metal frame of the battery case was ¿intact¿ but that melted material from the monitor prevented access to the battery itself.X-ray examination showed damage to at least one battery cell and also a tiny ¿bulge¿ of the metal frame surrounding the battery in the location of the positive terminal of this cell in question.A consensus decision was reached to not disassemble further to avoid further damaging the battery.A cat scan was performed to retrieve further identification information on the battery, but results of the cat scan have not been provided to philips.According to philips¿ records the battery field change order (fco86000255b) has been applied to the vs4 in question.This means that it is running the software with enhanced battery management.The unit was likely purchased 8 years ago (2016) when the medical facility was built.It is unknown whether the unit was new (through philips distribution) or used (through a 3-rd party) as, according to the fca, purchasing records were not available from the medical facility.Records about the battery (origin/purchase/maintenance) were also not available.Therefore, philips is unable to determine the age of the batteries being used.No problems with the unit were noted prior to this incident.It is unknown what type of battery was used for the device.It is also unknown whether the customer was following the battery maintenance guidelines from the ifu.Communication regarding investigation is handled by philips legal/risk management departments and the insurer¿s legal department.Information has not been readily forthcoming from the insurer¿s legal team.An iia was initiated (iia-2970-2022-508-001).A complaint search for the iia determined that no other complaints (other than this pr and possible duplicate (b)(4)) resulted in harm to the patient or property in the 3 years¿ timeframe of the search.Philips is unable to confirm whether the two related complaints are duplicates due to the customer¿s refusal to communicate with philips directly.The device is unusable and was removed from service.H3 other text: device was destroyed.

• Brand Name: SURESIGNS VS4 NBP, SPO2
• Type of Device: SURESIGNS VS4 NBP, SPO2
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13932061
• MDR Text Key: 288176535
• Report Number: 1218950-2022-00265
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838087095
• UDI-Public: 00884838087095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 863283
• Device Catalogue Number: 863283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2016
• 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