MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for SIMPLYGO MINI 1113602 manufactured by Philips Respironics Inc..
[177790688]
The manufacturer received information alleging an oxygen concentrator that shut down during patient use. The patient was admitted to the hospital. 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
[184085203]
The manufacturer previously reported an oxygen concentrator that allegedly shut down during patient use. The patient was admitted to the hospital. The device was returned to the manufacturer's product investigation laboratory for further evaluation. The device's downloaded event log was reviewed and was found to have no errors related to the event. The device was tested and was found to operate and alarm to design specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518422-2020-00292 |
| MDR Report Key | 9671072 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-03-22 |
| 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 | ADAM PRICE |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal | 15668 |
| Manufacturer Phone | 7243349303 |
| Manufacturer G1 | PHILIPS RESPIRONICS INC. |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15668 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15668 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIMPLYGO MINI |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-02-07 |
| Model Number | 1113602 |
| Catalog Number | 1113602 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-02-05 |