MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for OXYCON PRO 001-143960 manufactured by Carefusion.
[38483155]
(b)(4). This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdrs following the issuance of a 483. At this time the device is functioning as intended and is in normal operation. Should additional information become available a supplemental report 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
[38483157]
The customer reported that while doing a test the treadmill unexpectedly stopped. 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 the treadmill time out had to extended from 3000 to 10,000 milliseconds and a corrupted nonin 7600 driver was found and changed for a nonin 8600 driver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03156 |
| MDR Report Key | 5428961 |
| Date Received | 2016-02-10 |
| Date of Report | 2014-02-12 |
| Date of Event | 2014-02-12 |
| Date Mfgr Received | 2014-02-12 |
| Date Added to Maude | 2016-02-10 |
| 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 PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| 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 | OXYCON PRO |
| Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
| Product Code | BZC |
| Date Received | 2016-02-10 |
| Model Number | OXYCON PRO |
| Catalog Number | 001-143960 |
| 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 | 2016-02-10 |