MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 22 777404-101 manufactured by Carefusion, Inc.
[70316847]
(b)(4). Device evaluation: 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, then a computer error occurred. 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
[70316848]
The customer reported that while using the static and dynamic compliance, the track master treadmill dom 220v stopped while performing an exercise study on a patient. The customer reported that there was no patient harm or injury associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2017-05602 |
| MDR Report Key | 6411085 |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-16 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2016-12-27 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2017-03-16 |
| 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 | 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 | 2017-03-16 |
| Model Number | VMAX ENCORE 22 |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-03-16 |