MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-05-24 for STATIC AND DYNAMIC COMPLIANCE 22 777404-101 manufactured by Carefusion, Inc.
[45815147]
(b)(4). Results of investigation: the carefusion failure analysis lab received the device and performed a failure investigation. The customer's reported issue was duplicated and it was also noted that the power supply had a burning component once turned on.
Patient Sequence No: 1, Text Type: N, H10
[45815148]
The customer states that she is getting leak errors and there is a squealing noise when inhaling oxygen for nitrogen washout test. It is unknown whether there was any patient involvement. It was noted on the failure analysis that the power supply had a burning component once turned on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031702-2016-00650 |
| MDR Report Key | 5676389 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-05-24 |
| Date of Report | 2015-02-18 |
| Date of Event | 2015-02-18 |
| Date Mfgr Received | 2016-05-02 |
| Date Added to Maude | 2016-05-24 |
| 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 Phone | 7149227830 |
| 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 | 3 |
| Brand Name | STATIC AND DYNAMIC COMPLIANCE |
| Generic Name | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
| Product Code | BTY |
| Date Received | 2016-05-24 |
| Returned To Mfg | 2015-03-13 |
| Model Number | 22 |
| Catalog Number | 777404-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-05-24 |