MAUDE Adverse Event Report: INVACARE TAYLOR STREET PERFECTO2 V OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number IRC5PO2V

Device Problems Circuit Failure (1089); Sparking (2595)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

H6: the previous device manufacturer advised ventec that they have requested additional information about the event, as well as the return of the device to them for investigation.Upon completion of the previous device manufacturer's investigation ventec shall be provided with the results.A follow-up report will then be submitted when the investigation is complete as defined by 21 cfr 803.56.H3 other text : not returned to manufacturer.

Event Description

The following event was reported to ventec by the device's previous manufacturer: "after a period of normal operation, the equipment sparked and began to smell burning.Patient detected a burning smell.¿ there was patient involvement associated with the reported event; however, there was no patient harm as a result of the reported issue.No further details about the patient was provided.In addition, the previous manufacturer advised ventec that the event occurred sometime between (b)(6).The device's previous manufacturer also advised ventec that the udi information for the device was not available, therefore section d4, 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 d3, manufacturer and section g2, manufacturing site, of this initial medwatch report should actually state: manufacturer name: invacare suzhou manufacturer street 1: no.5 weixi road, sip manufacturer city: suzhou, jiangsu manufacturer country: chn manufacturer postal code: 215121.Section e1, initial reporter, of this initial medwatch should state: reporter first name: unknown reporter last name: unknown reporter facility name: (b)(6).

• Brand Name: PERFECTO2 V 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 17981363
• MDR Text Key: 326262725
• Report Number: 3013095415-2023-00664
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IRC5PO2V
• Device Catalogue Number: IRC5PO2V
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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