MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-05 for INVACARE PERFECTO2 V OXYGEN CONCENTRATOR IRC5PO2V manufactured by Invacare Florida.
[178374950]
Photographs of the concentrator were provided, which show discoloration of the cabinet's exterior near the inlet filter and cabinet filter door. Also, remnants of the cabinet filter are present on the filter door. The dealer stated that the unit was used at night on setting 3. It was positioned in the center of the laundry room, which had ventilation. The dealer tested the outlet that the unit was plugged into, and he stated it was good. The dealer advised that the end user does not smoke, nor does anyone else in the home. The dealer indicated that the unit is a rental and was provided to the end user on (b)(6) 2019. He stated that they do not perform maintenance on the unit, but the bacterial filter was replaced and the other filters were cleaned before the unit was provided to the end user. The unit was also tested for oxygen purity. This incident is being reported to the fda out of an abundance of caution, based on the evidence that the overheating event exited the shroud. 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 concentrator was returned to invacare and is pending further evaluation. Once the evaluation results are available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178374951]
The dealer reported that the end user alleged they heard a loud bang which woke them, and they found that the irc5po2v concentrator had caught on fire. The dealer indicated that the fire started internally and came out through the cabinet filter door. The dealer alleged the cabinet filter melted and dripped down, causing damage to the end user's floor. The end user was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2020-00003 |
| MDR Report Key | 9671298 |
| Report Source | OTHER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-12 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2017-05-12 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Returned To Mfg | 2020-01-31 |
| Model Number | IRC5PO2V |
| Catalog Number | IRC5PO2V |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-05 |