MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-02-24 for SERVO EVAC 180 9151465 manufactured by Maquet Critical Care Ab.
[18889047]
It was reported that while the ventilator was connected to a pt the attached open gas evacuation sys's bag became very big and it couldn't release the gas. The ventilator and the open gas evacuation sys were replaced. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19071101]
Our field svc engineer who was dispatched to the hosp examined both the ventilator and the gas evacuation sys. The fse found both of them functioning normally. No parts were replaced and both were returned to svc. The cause of the reported experienced difficulty has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010042-2015-00078 |
| MDR Report Key | 4552948 |
| Report Source | 01,05,06,07 |
| Date Received | 2015-02-24 |
| Date of Report | 2015-01-27 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-01-27 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2015-03-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MAGNUS LINDGVIST |
| Manufacturer Street | 2 ROENTGENVAGEN |
| Manufacturer City | SOLNA S-17154 |
| Manufacturer Country | SW |
| Manufacturer Postal | S-17154 |
| Manufacturer Phone | 7307705 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERVO EVAC 180 |
| Product Code | CBN |
| Date Received | 2015-02-24 |
| Catalog Number | 9151465 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CRITICAL CARE AB |
| Manufacturer Address | SOLNA SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-24 |