MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for MECHANICAL VENTILATOR SERVO-I manufactured by Maquet Medical Systems Usa.
[72948253]
Patient's vent was alarming and a unusual smell was coming from the vent. Vent was running on back up battery even though it was plugged into the electrical outlet. Vent was immediately taken out and a new one was replaced. Patient was not harmed and is safe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069090 |
| MDR Report Key | 6493071 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-03-27 |
| Date of Event | 2017-03-10 |
| Date Added to Maude | 2017-04-14 |
| 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 | RISK MANAGER |
| 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 | MECHANICAL VENTILATOR |
| Generic Name | MECHANICAL VENTILATOR |
| Product Code | ONZ |
| Date Received | 2017-04-12 |
| Model Number | SERVO-I |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET MEDICAL SYSTEMS USA |
| Manufacturer Address | 45 BARBOUR POND DRIVE WAYNE NJ 07470 US 07470 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-12 |