MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300; POWER WHEELCHAIR

Model Number	M300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/17/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Received report claiming the end-user had went outside to smoke a cigarette while using an oxygen tank.Witnesses claim having seen the end-user on the ground, on fire, while the device was also burning.Police reports indicate the staff had extinguished the end-user and device and attempted to render aide to the end-user, but they subsequently died while at the hospital, presumably from their injuries.Photos provided indicate the device had received extensive damages as a result of the thermal activity.Also shown was an e size oxygen tank with regulator depicting signs of oxidation on the outside of the tank and bag indicating extensive thermal activity having been present.Interviews with investigating authorities indicated no criminal wrong-doing, but classified it as a horrible accident.Reports provided to permobil indicate the damages sustained to the end-user and device were from an external source and no allegations were made of a device malfunction or deviation had contributed to this event.The dhr was reviewed and device met specification prior to distribution.The device is reported as being held by the local investigatory bodies and it is unclear if it will be released.If further information is received, a follow-up report will be submitted.
Event or Problem Description
Received report indicating the end-user had deceased after having caught on fire while occupying their mobility device.Reports claim a bystander having seen a man on the ground, on fire, laying in front of their power wheelchair which was also burning.

• Brand Name: PERMOBIL M300
• Common Device Name: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• MDR Report Key: 8624636
• Report Number: 1221084-2019-00017
• Device Sequence Number: 1643984
• Product Code: ITI
• UDI-Device Identifier: 17330818123401
• UDI-Public: 17330818123401
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: M300
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Weight: 168