MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-24 for STATIC AND DYNAMIC COMPLIANCE 22 E 24-777494 manufactured by Carefusion, Inc.
[58356498]
(b)(4). Results of investigation: the carefusion failure analysis lab received the suspected component and performed a failure investigation. The reported issue was a burnt mass flow sensor board in the laboratory setting. The root cause of the reported issue was found to be a burnt capacitor, c35, on the board. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10
[58356499]
The customer reported her vmax encore 22e module is no longer working. During testing she got a warning that the software is incompatible and could smell something burning. It is unknown if there was any patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031702-2016-01176 |
| MDR Report Key | 6051788 |
| Date Received | 2016-10-24 |
| Date of Report | 2016-10-24 |
| Date of Event | 2013-01-17 |
| Date Mfgr Received | 2016-10-11 |
| Date Added to Maude | 2016-10-24 |
| 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 |
| 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 G1 | CAREFUSION, INC |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| 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 | 2016-10-24 |
| Returned To Mfg | 2013-01-31 |
| Model Number | 22 E |
| Catalog Number | 24-777494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 1100 BIRD CENTER DRIVE PALM SPRINGS CA 92262 US 92262 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-24 |