MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for BLEASEDATUM ANAESTHESIA VAPORIZER manufactured by Spacelabs Healthcare Ltd..
[104432488]
Spacelabs has identified this device as being manufactured in 1995. Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[104432489]
Spacelabs received a report on (b)(6) 2018 that the bleasedatum sevoflurane vaporizer failed to deliver the anesthetic agent while in use on a patient. The clinician noted this failure, corrected the issue, and documented accordingly. No injury was reported with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611295-2018-00025 |
| MDR Report Key | 7393907 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-01-17 |
| Date Mfgr Received | 2018-03-30 |
| Device Manufacturer Date | 1995-01-10 |
| Date Added to Maude | 2018-04-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL FREY |
| Manufacturer Street | 35301 SE CENTER ST. |
| Manufacturer City | SNOQUALMIE WA 98065 |
| Manufacturer Country | US |
| Manufacturer Postal | 98065 |
| Manufacturer Phone | 425 363-56 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLEASEDATUM ANAESTHESIA VAPORIZER |
| Generic Name | ANAESTHESIA VAPORIZER |
| Product Code | CAD |
| Date Received | 2018-04-03 |
| Model Number | BLEASEDATUM |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS HEALTHCARE LTD. |
| Manufacturer Address | UNIT B, FOXHOLES CENTRE JOHN TATE ROAD HERTFORD SG137NW UK SG13 7NW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-03 |