MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-28 for VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS 229 E 777400-101 manufactured by Carefusion.
[30219401]
(b)(4). Once the device is returned for evaluation and additional information is received a follow up will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[30219402]
The customer reported experiencing computer freeze-ups that were occurring 2-3 times a week. During a treadmill test, one of their protocol settings was not transferred correctly. The treadmill speed was supposed to be set at 0. 6 mph and it jumped up to 2. 5 mph on an elderly lady. She did not fall nor was there any incident resulting from this as the therapist was able to manually decrease the speed.
Patient Sequence No: 1, Text Type: D, B5
[32988622]
An evaluation was performed by a carefusion failure analysis technician on the dell xe2 computer. The reported complaint was duplicated by powering up the computer and the screen showed? Windows could not start because of a computer disk hardware configuration problem.? This behavior was found to occur if the default value in the boot. Ini file is missing or invalid, windows xp is not installed in the location specified in the boot. Ini file, the ntoskrnl. Exe file is missing or damaged, the partition path in the boot. Ini file is not set correctly or because of a general hardware failure. In conclusion, it was determined that there was an issue with the hardware configuration.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2015-02075 |
| MDR Report Key | 5186011 |
| Date Received | 2015-10-28 |
| Date of Report | 2015-10-12 |
| Date of Event | 2015-09-17 |
| Date Mfgr Received | 2015-12-01 |
| Device Manufacturer Date | 2005-04-01 |
| Date Added to Maude | 2015-10-28 |
| 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 | 3 |
| Brand Name | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2015-10-28 |
| Returned To Mfg | 2015-11-18 |
| Model Number | 229 E |
| Catalog Number | 777400-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-10-28 |