MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for OXYCON MOBILE 001-143250 manufactured by Carefusion, Inc.
[41663501]
This mdr is being submitted due to a retrospective complaint review performed by carefusion. The carefusion identification file is (b)(4). The device was evaluated at the customer's facility by a carefusion field service engineer (fse). He was unable to duplicate the reported event. As a correction, the fse installed the hotfix software and did a system calibration. Carefusion continues to track and trend any incident related to this issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41663502]
The customer reported the emergency stop function on their nordictrack x9i treadmill causes the (b)(4) software to shut off. When the software shuts off so does the ecg and breath by breath monitoring. There was no known patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[43735235]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[43735236]
The customer reported the emergency stop function on their nordictrack x9i treadmill causes the jlab software to shut off. When the software shuts off so does the ecg and breath by breath monitoring. The customer did not clarify if there was patient involvement or not, it is currently unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03409 |
| MDR Report Key | 5536781 |
| Date Received | 2016-03-30 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-03-31 |
| Date Mfgr Received | 2016-04-21 |
| Date Added to Maude | 2016-03-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8473628056 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | LIEBNIZSTRASSE 7 |
| Manufacturer City | HOECHBERG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYCON MOBILE |
| Generic Name | CALCULATOR, PULMONARY FUNCTION DATA |
| Product Code | BZC |
| Date Received | 2016-03-30 |
| Model Number | OXYCON MOBILE |
| Catalog Number | 001-143250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | LIEBNIZSTRASSE 7 HOECHBERG 97204 GM 97204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-30 |