MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-11 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 29 UNIT ASSEM 229C E manufactured by Carefusion, Inc.
[60083620]
(b)(4). No device or parts will not be returned to carefusion for evaluation. The customer reran the protocol and the reported issue was not observed so the customer has stated they only want to document the issue and will not be returning the device for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[60083621]
The customer reported that trackmaster treadmill stopped fourteen minutes into the exercise phase using the modified mvo2 protocol. The device was in use on a patient at the time of the event; however, there was no injury to the patient. The customer later ran a mock test using the same protocol and the treadmill did not stop.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-04833 |
| MDR Report Key | 6097717 |
| Date Received | 2016-11-11 |
| Date of Report | 2016-11-11 |
| Date of Event | 2016-10-14 |
| Date Mfgr Received | 2016-10-14 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2016-11-11 |
| 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 | 0 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-11-11 |
| Model Number | VMAX ENCORE 29 UNIT ASSEM |
| Catalog Number | 229C E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-11-11 |