MAUDE Adverse Event Report: INVACARE TAYLOR STREET UNKNOWN; GENERATOR, OXYGEN, PORTABLE

Model Number UNKNOWN

Device Problems Fire (1245); Melted (1385)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Event Description

Ventec was provided with a copy of a court summons in which the previous device manufacturer, invacare, is listed as a defendant in a personal injury claim."plaintiff, 'po' [redacted] files this action to recover for harms and losses she suffered while using an oxygen concentrator that occurred on or about (b)(6) 2023, when the concentrator malfunctioned a month after it's delivery, causing plastic tubing to melt onto her body." plaintiff had used the subject oxygen concentrator for three months prior to this incident.The month prior to this incident, [additional] defendant lincare holdings replaced and installed different oxygen tubing in the subject concentrator.The use of the oxygen concentrator required an oxygen tube to be placed in plaintiffs nose.At approximately 3:00 a.M., on (b)(6) 2023, plaintiff was asleep on her couch with the oxygen concentrator running and the oxygen tubing inserted.The excess tubing was resting in plaintiff's lap.At approximately 3:00 a.M.On (b)(6) 2023, plaintiff abruptly awoke to the smell of burning and an extremely painful burning sensation on her face, tongue, legs, arms, hands, and genital area.While plaintiff was asleep, the concentrator ignited, caused the oxygen tubing to overheat and melt onto plaintiff's body, causing second and third degree bums to plaintiff's face, tongue, body, legs, arms, fingers, and genitalia.Fire investigators arrived on scene and determined that there was fire present at the concentrator and along the tubing leading to plaintiff.Fire investigators performed an inspection and determined there were no external ignition sources that could have caused the incident inside the home or exterior trash can, including candles, stove tops, lighters, matches, or cigarettes." no further details about the patient or the event were provided.The summons did not describe the medical treatment that was sought by, or provided to, the patient.The serial number of the oxygen concentrator was not provided to the previous device manufacturer, nor is it listed in the provided summons.As a result, section d1, brand name, and section d4 (model number, catalog number, serial number and udi number) are "unknown", and section h4 (device manufacturing date) shall be left blank.

Manufacturer Narrative

H6: the device has not been returned to ventec for evaluation.The previous device manufacturer, who has been named in the aforementioned litigation, will investigate the reported event.Upon completion of the previous device manufacturer's investigation, ventec shall be provided with the results.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.H3 other text : not returned to manufacturer.

• Brand Name: UNKNOWN
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: elizabeth gilbert ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 18979962
• MDR Text Key: 338618762
• Report Number: 3013095415-2024-00286
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention