MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA CM100

Model Number 863300

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 efficia cm100 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, (b)(6) 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, nor was there a report of any adverse impact to any user or patient.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 batteries onboard are being addresses by individual complaints.As the batteries were identified as being the only potential ignition source, there was no malfunction of the efficia device.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.Analysis was performed and investigation has been completed.The burnt devices remain in the possession of philips.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: EFFICIA CM100
• Type of Device: EFFICIA CM100
• 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 rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16632982
• MDR Text Key: 312203155
• Report Number: 1218950-2023-00163
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151812
• 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
• Report Date: 03/29/2023

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: 863300
• Device Catalogue Number: 863300
• 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