MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-23 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22 777404-101 manufactured by Carefusion, Inc.
[61094402]
(b)(4). At this time, carefusion has not received the suspect device/component for evaluation. The customer has reported that the device was checked out by a technician and the reported issue could not be duplicated. The customer considers the issue resolved and no further evaluation or return of the device is expected. Should additional information become available a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[61094403]
The customer reported that while using the static and dynamic compliance, the track master treadmill (b)(4) stopped during patient use. The incident occurred twice in one study. The customer reported that there was no patient harm or injury.
Patient Sequence No: 1, Text Type: D, B5
[69985764]
A vyaire field service representative (fsr) was dispatched to evaluate the system. The fsr was unable to duplicate the reported problem. After review of computer logs, it was determined anti-virus software scanned during patient testing, resulted in a computer error. The customer was provided information regarding the use of the product and anti-virus software scanning and that scanning must be disabled during patient testing.
Patient Sequence No: 1, Text Type: N, H10
[70198144]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2016-04933 |
| MDR Report Key | 6125913 |
| Date Received | 2016-11-23 |
| Date of Report | 2017-03-16 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2017-03-16 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2016-11-23 |
| 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 | RESPIRATORY THERAPIST |
| 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 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 | 3 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-11-23 |
| Model Number | VMAX ENCORE 22 |
| 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 | 1. Other | 2016-11-23 |