MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-26 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 29C 777409-101 manufactured by Carefusion, Inc.
[46010327]
(b)(4) results of investigation: the device was evaluated by a carefusion field service engineer on-site. He was able to duplicate the problem and it was resolved by upgrading the firmware from version 2. 1 to 2. 2 and adjusting the timeout settings. The device is currently working to service specifications with no parts replaced or returned.
Patient Sequence No: 1, Text Type: N, H10
[46010328]
The customer reported her system has intermittent graphics issues as well as the treadmill shut off in middle of test. She was running an exercise test on a female, young adult. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03797 |
| MDR Report Key | 5682231 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-04 |
| Date of Event | 2016-05-04 |
| Date Mfgr Received | 2016-05-04 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2016-05-26 |
| 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 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 | 3 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-05-26 |
| Model Number | VMAX ENCORE 29C |
| Catalog Number | 777409-101 |
| 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 | 2016-05-26 |