MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-07 for NLA - NO RPLMT PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 NA:IRC5PO2 IRC5PO2 manufactured by Invacare Florida.
[178160143]
Invacare was made aware of this event that took place in germany involving an irc5po2-de concentrator. The concentrator was manufactured by invacare suzhou, however, they are no longer in business. Therefore, this medwatch is being filed to invacare florida where they are currently manufactured. Invacare is filing this complaint in an abundance of caution due to a similar device is sold by invacare in the u. S. It is unclear if/how/when the tubing became disconnected. The user manual part # 1143482-h-00 states: page6 1. 2 intended use the intended function and use of the invacare? Perfecto2? Oxygen concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life. Danger! Risk of injury or death. This product is to be used as an oxygen supplement and is not intended to be life-supporting or life-sustaining. Only use this product if the patient is capable of spontaneous breath, able to inhale and exhale without the use of a machine. 1. 3 indications for use: the intended function and use of the invacare? Perfecto2? V oxygen concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life. Page 7 1. 4 description: the invacare perfecto2 concentrator is used by patients with respiratory disorders who require supplemental oxygen. The device is not intended to sustain or support life. The dealer stated he could not duplicate the issue. The dealer states the device will not be returned because the concentrator is in use by another patient. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[178160144]
During the night of (b)(6) 2019, the end-user suffered a heart attack while using an irc5po2 concentrator. The next morning, the end-user's son noticed that the connecting tube from the concentrator to the humidifier was hanging loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1031452-2020-00004 |
| MDR Report Key | 9681490 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-07 |
| 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 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| 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 | NLA - NO RPLMT PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-07 |
| Model Number | NA:IRC5PO2 |
| Catalog Number | IRC5PO2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Death | 2020-02-07 |