MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-20 for VAPOTHERM manufactured by Vapotherm.
[145780464]
My mother, (b)(6) who is inpatient and admitted to (b)(6) medical center (b)(6) with pulmonary fibrosis and initially required 100% oxygen was able to improve over the course of 2-3 weeks and was down to 45% oxygen and maintaining sat above 90. On (b)(6) 2019, the vapotherm was beeping for a period of time for no reason. The nurses weren't concerned but after about an hour, pulmonary therapist came in and played with it to get the beeping to stop which it did. However on (b)(6) 2019, the machine malfunctioned and my mother went into respiratory distress until the nurses came in and put her on another form of oxygen until they could get another vapotherm unit. My mother has since struggled to breath and has been increased back to 80% oxygen. Please research. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086782 |
| MDR Report Key | 8627756 |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-12 |
| Date Added to Maude | 2019-05-21 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | VAPOTHERM |
| Generic Name | REGULATOR, PRESSURE, GAS CYLINDER |
| Product Code | CAN |
| Date Received | 2019-05-20 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VAPOTHERM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit | 2019-05-20 |