MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-09 for VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS 229C E 777410-101 manufactured by Carefusion.
[31016989]
The carefusion file identification number is (b)(4). At this time the device is functioning as intended and is in normal operation. Carefusion continues to track and trend any incident related to this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31016990]
It was reported by the customer that while doing a test the treadmill abruptly stopped. It went from a speed of 2 miles per hour and a grade of 10. 5 to zero. There was no patient harm or injury reported. A carefusion field service technician (fst) inspected the treadmill and all of its connections and ran a test protocol study without issue. All factors and settings were found to be within specifications. It was determined that there were network issues at the facility which caused the loss of communication between the device and the treadmill.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2015-02172 |
| MDR Report Key | 5212810 |
| Date Received | 2015-11-09 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-10-22 |
| Date Mfgr Received | 2015-10-26 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2015-11-09 |
| 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 | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION |
| 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 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2015-11-09 |
| Model Number | 229C E |
| Catalog Number | 777410-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-09 |