MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC MX40 LITHIUM-ION BATTERY PKG 3

Model Number 989803174131

Device Problems Battery Problem (2885); Excessive Heating (4030)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

The customer reported that a device battery while being transported cause a vehicle fire.There was no reported adverse event to the patient or user.

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.Reporting address state: (b)(6).

Event Description

Philips received a complaint on the mx40 lithium-ion battery pkg 3 indicating that while in transport from a philips warehouse a semi tractor trailer became engulfed in flames requiring roadway intervention from emergency service personnel.On (b)(6) 2023, several german road users reported a burning truck on the hard shoulder of highway 8 shortly before the neuhausen auf den fildern exit at around 1:00 p.M.The truck driver was traveling there from stuttgart in the direction of ulm when he noticed smoke developing from the direction of the loading area shortly before 1:00 pm.The driver stopped on the hard shoulder and tried to extinguish the fire that had started in the semitrailer with two fire extinguishers.As this did not succeed, he uncoupled the tractor unit for safety reasons.In the meantime, a large column of smoke had developed, which at times also led to visibility obstructions on the highway.The fire department was called in and was able to extinguish the trailer, which was on fire, but the load of medical equipment was completely destroyed by the fire.During the extinguishing, recovery and cleaning work, initially only the left lane was passable.At around 2:15 p.M., the middle lane was also cleared, and at around 3:30 p.M.All three lanes were free again.This resulted in traffic stretching back for approximately 6 kilometers / 3.7 miles.Local air traffic was not impacted.There was no report of a death or serious injury.The severely charred remains were collected and taken to a philips facility where they were preserved inside of a tent.The burnt trailer remained available for investigation.

Manufacturer Narrative

Third party investigation service gottwald and back was hired to investigate the burnt remains.Photographic evidence was provided and confirms the burned, extremely degraded state of the medical devices.The semitrailer was evaluated for any signs of the fire source.Visual inspection found that the fire was not the result of the semitrailer.The outside and undercarriage were examined and were proven not to be the source of the fire.The inside of the semitrailer was examined and confirmed not to be the cause of the fire.The investigation service discovered 2 burn through holes on the wood flooring of the semitrailer.The investigation service noted that the only ignition source on the truck was the battery packs with lithium ions cells.The investigation service spent 2 days sorting through the debris to locate all of the battery cells that remained.They attempted to sort by the 4 different kinds of battery cells onboard, however this task was described as difficult to impossible as a result of the severe fire."since most of the cells were severely damaged by fire, the assignment was often difficult or impossible.Colour distinctions were often no longer recognizable.In some cases, the cells could be identified by the remains of soldering lugs or the characteristic arrangement of cells that were still connected.If plastic parts were still present, it was sometimes possible to assign the cell to a certain type by using different insulating materials.In order to better identify the cells, it was also necessary to disassemble well-preserved battery packs in order to analyze their internal structure." the investigators were however able to identify several of the batteries: "nevertheless, a remainder of cells that could not be allocated.In addition, the battery packs found were examined with regard to their remaining voltages.This was also done in order to be able to assess the risks still emanating from them.In addition, 13 battery aa-cells (not accumulators) were found in the fire debris.In addition, 18 18650 cells were found that had obviously reacted.In other words, an internal short circuit had occurred.The lid was missing on 12 of them.They also had symptomatic deformations.Another 4 were still available with lids and all had a safety valve with 6 holes.This means that they belong to the manufacturers sony or panasonic (lg only has 4 holes)." the investigation service confirmed that there were 1163 battery cells in 137 packs in the truck load.Of these, 189 are no longer present and therefore were unable to be investigated.These cells were lost during the roadway clean up or reloading of the debris.The investigation service performed examinations and voltage testing on the 13 battery aa-cells that remained.Examinations were preformed of the remaining destroyed batteries.Results of functional testing indicate that the truck and semitrailer were not the cause of the fire.As a result of the severe damage to the fire the investigators are unable to rule out a specific type of battery as the cause of the fire.The investigation results are inconclusive, the root cause of the fire remains unknown.Analysis was performed and investigation has been completed.The burnt battery cells will be held by the investigation team for a period not longer than 1 year.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : device evaluated by third party investigation.

• Brand Name: MX40 LITHIUM-ION BATTERY PKG 3
• Type of Device: MX40 LITHIUM-ION BATTERY PKG 3
• 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: hisham alzayat ; 3000 minuteman road; andover, MA 01810 ; 9786593000
• MDR Report Key: 16633019
• MDR Text Key: 312206245
• Report Number: 1218950-2023-00165
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K041741
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 989803174131
• Device Catalogue Number: 989803174131
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1