MAUDE Adverse Event Report: INVACARE TAYLOR STREET PERFECTO2V OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number IRCPO2V

Device Problem Fire (1245)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

H6: ventec continues to investigate the reported event.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.

Event Description

The following event was reported to ventec by the device's previous manufacturer: "der nutzer hat sich zur mittagszeit hingelegt, die nasenbrille genutzt und ist dann eingeschlafen.Durch einen lauten knall ist dieser aufgewacht und hat das schlauchsystem brennen gesehen.Darauf hin versuchte die ehefrau, die flammen mit einem handtuch zu löschen.Auf dem boden traten brandschäden auf." german to english translation: "the user lay down at lunchtime, used the nasal cannula and then fell asleep.He was woken up by a loud bang and saw the tube system burning.The wife then tried to put out the flames with a towel.There was fire damage on the floor.¿ the year of the patient's birth was reported as "1954".No further details about the patient or the event were provided to ventec.The previous device manufacturer advised ventec that the serial number and udi information for the device was not available, therefore section d4, serial # as well as udi, is "unknown".Due to a technical issue with ventec's electronic medwatch submission platform, we are unable to enter ous contacts in our esub form and have instead entered in the domestic (usa) reporter's information.Section e1, initial reporter, of this initial medwatch report should actually state: reporter first name: (b)(6), reporter last name: (b)(6), reporter facility name: (b)(6), reporter street 1: (b)(6), reporter city: (b)(6), reporter state: none, reporter postal code: (b)(6), reporter country: (b)(6), reporter email: (b)(6).

• Brand Name: PERFECTO2V OXYGEN CONCENTRATOR
• 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: 18637038
• MDR Text Key: 334489734
• Report Number: 3013095415-2024-00106
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRCPO2V
• Device Catalogue Number: IRCPO2V
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Sex: Male