MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-12 for INVACARE PERFECTO2 V OXYGEN CONCENTRATOR IRC5PO2V manufactured by Invacare Florida.
[183731050]
The dealer advised that the customer is not a smoker, and it didn't appear that the unit had been tampered with. Photographs of the concentrator were provided, which show deformation to the left sieve bed cap and discoloration of the attached tubing, indicating that an overheating event had occurred. Additionally, the photos show discoloration and deformation of the cabinet's exterior near the inlet filter and cabinet filter door, indicating that the overheating event exited the shroud. Based on this evidence that the overheating event exited the shroud, this incident is being reported to the fda out of an abundance of caution. This failure mode has been previously identified and investigated. The investigation activities concluded that the failure is unlikely to occur when the system is operating under normal conditions or a single fault condition. Rather, the system likely has to experience multiple faults to result in the failure observed. Even though the failure is unlikely to occur, components of the irc5po2v concentrator have been updated to prevent potential recurrence of this issue. The subject concentrator was manufactured prior to implementation of these updates. The device has been returned to invacare for further evaluation. Once the evaluation results are available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183731051]
The dealer reported that the irc5po2v concentrator had signs that a fire had occurred, though a fire was not actually witnessed. The dealer stated that the inside of the unit had melted in the area of the left sieve bed and pe valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2020-00006 |
| MDR Report Key | 9823634 |
| Report Source | OTHER |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE FLORIDA |
| Manufacturer Street | 2101 EAST LAKE MARY BLVD |
| Manufacturer City | SANFORD FL 32773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE PERFECTO2 V OXYGEN CONCENTRATOR |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2020-03-04 |
| Model Number | IRC5PO2V |
| Catalog Number | IRC5PO2V |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE FLORIDA |
| Manufacturer Address | 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |