MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3; POWERED WHEELCHAIR

Model Number F3

Device Problem Electrical Shorting (2926)

Patient Problem Pulmonary Emphysema (1832)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

Permobil received report from service provider of having received a call from the end-user claiming some sort of thermal activity occurred on their device.End-user alleged that this event caused the whole home to fill up with smoke to which they inhaled.End-user alleges after having inhaled this smoke, it caused them to contract emphysema to which they report not having had before this alleged incident occurred.At the time of this report, the end-user has not provided any medical documentation to support their allegation of injuries.Service provider arrived to inspect the device and noted several cables located on the base chassis, under the shroud, shown signs on some sort of thermal activity having occurred with the outer casing of the cabling having melted.After review of photos submitted of the affected components, combined with testimony of the technician who performed the inspection, permobil is unable to determine the root cause of the reported incident at this time.Permobil has requested the device be retrieved and returned to permobil for a more in-depth evaluation.A follow-up report will be submitted after device evaluation has been completed.

Event Description

Received report alleging thermal activity having occurred with the device cabling which reported to have filled up the end-user's home with smoke.End-user alleges the inhalation of the smoke caused them to contract emphysema.

• Brand Name: PERMOBIL F3
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 8501003
• MDR Text Key: 141566317
• Report Number: 1221084-2019-00014
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: F3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 76