MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-08 for SIMPLYGO MINI 1113601 manufactured by Philips Respironics Inc..
[174137716]
The manufacturer received information alleging an oxygen concentrator was provided to the patient without the device instructions of use. The patient expired. The device is not life supporting or life sustaining. Repeated attempts to have the returned for evaluation and investigation were unsuccessful. The manufacturer believes they will be unable to gather additional information. The manufacturer is submitting a final report at this time. If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2020-00062 |
| MDR Report Key | 9564253 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2019-10-29 |
| 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 | SIMPLYGO MINI |
| Generic Name | GENERATOR, OXYGEN, PORTABLE |
| Product Code | CAW |
| Date Received | 2020-01-08 |
| Model Number | 1113601 |
| Catalog Number | 1113601 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS INC. |
| Manufacturer Address | 312 ALVIN DRIVE NEW KENSINGTON PA 15068 US 15068 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-08 |