MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for APNEA MONITOR 3705 manufactured by Resmed Ltd..
[6191429]
Client was having apnea spells. The oximeter alerted caregiver/nurses that client was experiencing difficulties. Upon arrival in client's room, it was noted that client was not breathing. Client was/is on bipap. Agnes monitor was noted to not be alarming client's chest was not rising. Dme company was notified, monitor exchanged for new monitor. Dme company was to download info and send to physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044785 |
| MDR Report Key | 4945814 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-06-28 |
| Date Added to Maude | 2015-07-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APNEA MONITOR |
| Generic Name | APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2015-07-23 |
| Model Number | 3705 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD. |
| Manufacturer Address | 1 ELIZABETH DRIVE NSW 2153 AS 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-23 |