MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5SC SPOTCHECK MONITOR

Model Number 865322

Device Problem Fire (1245)

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

Event Date 04/24/2023

Event Type  malfunction  

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site.The fse viewed a video of the event.They also visually inspected the device and reviewed photos of the device that were taken after the event.The fse determined the cause of the fire was likely a faulty third party battery.The fse will confirm with the customer that they were using a third party battery with the device.Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

Philips received a complaint on the intellivue mp5sc spotcheck monitor indicating that the device caught on fire.There was no patient involvement and no report of user harm.

Manufacturer Narrative

The field service engineer (fse) viewed a video of the event and visually inspected the device and reviewed photos of the device that were taken after the event.The images reviewed determined that the philips battery (b)(6)(battery 10.8v 6ah liion) is shown with the blue lithium cells, whereas the charred object being the customers 3rd party battery.The fse noticed the conductive strip in the burnt battery appears to end on lithium cell cap, whereas philips' continues down the side of the (b)(6).He also noticed there were two small wires soldered to the tab at the end of the lithium cell.Philips' design doesn¿t reflect this at all, instead using a single wire of a much larger gauge terminated on a different lithium cell.On a good faith effort (gfe) sent, the fse stated "i received confirmation from research and development (r&d) that my observations were correct, and we were able to conclude that this was not a philips battery involved in this fire." having verified that our battery is built on a different design that the battery shown, we concluded that this was not a philips (b)(6) battery which was involved in this fire.The fse determined the cause of the fire was likely a faulty third-party battery.The fse has confirmed that the battery involved was not a philips product.Moreover, per the instructions for use (ifu) page 322, there is a battery safety information that states: ¿warning ¿ use only philips batteries specified in the chapter on ¿accessories¿.Use of a different battery may present a risk of fire or explosion.¿ do not open batteries, heat above 60°c (140°f), incinerate batteries, or cause them to short circuit.They may ignite, explode, leak or heat up, causing personal injury.¿ if battery leakage should occur, use caution in removing the battery.Avoid contact with skin.Refer to qualified service personnel.¿ do not expose batteries to liquids.¿ do not apply reverse polarity.¿ do not crush, drop or puncture batteries ¿ mechanical abuse can lead to internal damage and internal short circuits which may not be visible externally.¿ if a battery has been dropped or banged against a hard surface, whether damage is visible externally or not: ¿ discontinue use ¿ dispose of the battery in accordance with the disposal instructions above.¿ keep batteries out of the reach of children.¿ based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.A review of the risk management file was performed, based on the global decision tree results this event was determined reportable for a fire, explosion or breach of the device has the potential to cause serious injury to patients, users and bystanders in the nearby area.A clinical harm review performed by pms clinical expert concluded that based on the information currently available in the complaint record, there was no report of actual harm associated with this complaint.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.Analysis was performed and investigation has been completed.The device has been discarded per local procedures.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE MP5SC SPOTCHECK MONITOR
• Type of Device: INTELLIVUE MP5SC SPOTCHECK MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 16974691
• MDR Text Key: 315673846
• Report Number: 9610816-2023-00241
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838021884
• UDI-Public: 00884838021884
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,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: 865322
• Device Catalogue Number: 865322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2014
• 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