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.
[177798099]
Photographs of the device were provided, which show that the product tank's plastic cap is broken, which is indicative that an over-pressurization event occurred. However, the product tank itself appears to be intact and remains in its intended position within the device. The tubing coming off the sieve bed caps appears to be discolored and sieve material is present within the tubing. This incident is being reported to the fda out of an abundance of caution, based on the evidence that the product tank experienced an over-pressurization event. 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
[177798100]
The dealer reported that the product tank within the irc5po2v concentrator exploded and the rear shroud blew off the back of the unit while the end user was eating dinner. The dealer also stated that the tubes within the unit are black.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2020-00002 |
| MDR Report Key | 9671211 |
| Report Source | OTHER |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2017-03-16 |
| 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 | 2020-01-27 |
| 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 |