MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for SYSTEM ONE RESPIRATOR manufactured by Phills / Respironics, Inc..
[101318312]
Fell twice, just dropped without any indications. Having dizzy spells. Feeling pressure between my ears (head) went to dr, said had defect in my left inner ear. Prescribed physical therapy, four sessions, no help. Felt better for a while. Possible side effects from combination of breathing machine, amlodipine besylate 5 mg, losartan 100-25mg aur, metformin hcl dr 500 mg tabs, insulin humalog and basaglar. An (b)(6) male. Dates of use: 2 years. Diagnosis or reason for use: sleep. "event abated after use stopped: no. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075570 |
| MDR Report Key | 7302441 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-23 |
| Date of Event | 2017-10-01 |
| Date Added to Maude | 2018-02-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYSTEM ONE RESPIRATOR |
| Generic Name | SYSTEM ONE RESPIRATOR |
| Product Code | BZK |
| Date Received | 2018-02-27 |
| Model Number | SYSTEM ONE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLS / RESPIRONICS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-02-27 |