MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-08 for EVERFLO OXYGEN CONCENTRATOR OPI 1020006 manufactured by Philips Respironics Inc..
[174180701]
The manufacturer received information alleging an oxygen concentrator had a short circuit and damage to the power cord. There was no report of patient harm or injury. The device has yet to be returned to the manufacturer for evaluation. A follow up report will be submitted when the manufacturer has completed the investigation.
Patient Sequence No: 1, Text Type: D, B5
[184069594]
The manufacturer previously reported an oxygen concentrator that allegedly had a short circuit and damage to the power cord. There was no report of patient harm or injury. The manufacturer incorrectly reported that there was evidence of thermal damage to the power cord. The power cord had evidence of physical damage causing the device to not be able to be placed into service. There was no evidence of thermal damage to the power cord.
Patient Sequence No: 1, Text Type: N, H10
[184073272]
The manufacturer previously reported an oxygen concentrator that allegedly had a short circuit and damage to the power cord. There was no report of patient harm or injury. The device was returned to the manufacturer's service center for evaluation. The customer's complaint was confirmed. The device has evidence of thermal damage to the power cord. The power cord was observed to have damage consistent with the application of excessive force by the end user. It appears the device was placed too close to a hard surface. This caused the power cord to bend, creating weakness in the power cord. Product labeling for the everflo oxygen concentrator states, "keep the device at least 15-30cm away from walls, furniture, and especially curtains that could impede adequate airflow to the device. Do not place the concentrator in a small closed space (such as a closet). " "do not use the oxygen concentrator if either the plug or power cord is damaged. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2020-00088 |
| MDR Report Key | 9564330 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2014-09-08 |
| Date Added to Maude | 2020-01-08 |
| 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 | ADAM PRICE |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal | 15068 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | PHILIPS RESPIRONICS INC. |
| Manufacturer Street | 312 ALVIN DRIVE |
| Manufacturer City | NEW KENSINGTON PA 15068 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15068 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERFLO OXYGEN CONCENTRATOR OPI |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2020-01-10 |
| Model Number | 1020006 |
| Catalog Number | 1020006 |
| 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 | PHILIPS RESPIRONICS INC. |
| Manufacturer Address | 1001 MURRY RIDGE LANE MURRYSVILLE PA 15668 US 15668 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |