MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-22 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22D 777405-101 manufactured by Carefusion, Inc.
[78355340]
(b)(4). The customer reported the suspect component is available for analysis and an return good authorization (rga) has been issued. At this time, carefusion has not received the suspect component for evaluation. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[78355341]
The customer reported while using the vmax encore, a smell of smoke was noticeable while warming up the unit. The issue occurred with no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[113563480]
The vyaire failure analysis lab received the suspected device and performed a failure investigation. The failure analysis technician confirmed burnt tracings on the analyzer control board (777348-101). The root cause is the operator error-assembly and is an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2017-06170 |
| MDR Report Key | 6661466 |
| Date Received | 2017-06-22 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-05-30 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2017-06-22 |
| 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 | KRISTIN GRAF |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2017-06-22 |
| Model Number | VMAX ENCORE 22D |
| Catalog Number | 777405-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-22 |