MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 229D W/O GAS REG 777401-103 manufactured by Carefusion, Inc.
[51885454]
(b)(4). The customer reported the suspect component is available for analysis and an return good authorization (rga) has been issued. At this time, carefusion has not received the suspect component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[51885455]
The company representative reported while using the static and dynamic compliance; the hot wires between pins of the flow sensor were melted. The customer stated the device was not used on a patient for pulmonary function testing at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[60503201]
Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor. Visual examination of the mass flow sensor, as received, revealed the filaments to be burned. The reported "middle hot wire between pins are melted" failure was confirmed. The failure analysis technician determined the root cause to be due to material fatigue. This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life. Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor. Visual examination of the mass flow sensor, as received, revealed the filaments to be burned. The reported "middle hot wire between pins are melted" failure was confirmed. The failure analysis technician determined the root cause to be due to material fatigue. This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life. Upon further risk assessment, there is no danger of patient harm or user harm at the time of the filament failure as the hot wires are contained inside the plastic sensor housing and do not come in contact with the end user or patient at any time during use. Therefore the initial mdr should have not been submitted. This failure is unlikely to cause harm or injury to a patient or user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2016-04158 |
| MDR Report Key | 5845462 |
| Date Received | 2016-08-03 |
| Date of Report | 2016-11-04 |
| Date of Event | 2016-07-19 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2010-05-01 |
| Date Added to Maude | 2016-08-03 |
| 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 | 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 | 2016-08-03 |
| Model Number | VMAX ENCORE 229D W/O GAS REG |
| Catalog Number | 777401-103 |
| 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 | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-03 |