MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-15 for STATIC AND DYNAMIC COMPLIANCE VMAX 777404-101 manufactured by Carefusion, Inc.
[52730272]
The carefusion identification file is (b)(4). (b)(4). At this time, carefusion has not received the suspect device/component for evaluation. Upon completion of a final evaluation, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[52730273]
The customer reported while using the static and dynamic compliance vmax device; the customer noted a burnt smell and a smoke from the unit. The customer stated the suspect device was not being used on a patient for pulmonary function testing at the time of the event, and that it was discovered during calibrations.
Patient Sequence No: 1, Text Type: D, B5
[113455512]
The vyaire failure analysis lab received the suspected device and performed a failure investigation. The failure analysis technician was able to confirm the burnt capacitor (c30). The root cause is the material fatigue and is an isolated incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2016-04236 |
| MDR Report Key | 5877350 |
| Date Received | 2016-08-15 |
| Date of Report | 2017-10-26 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2016-08-15 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| 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 | 2016-08-15 |
| Model Number | VMAX |
| Catalog Number | 777404-101 |
| 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 | 2016-08-15 |