MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-02-21 for SMARTMONITOR 2 PS 1014557 manufactured by Phillips Respironics - Chmv.
[4475349]
Children's medical ventures (chmv) received a report from (b)(6) stating that a smartmonitor 2 professional series (ps) device was "not passing one of the sensitivity points". The smartmonitor devices was reportedly being tested at the time the alleged failure and not in patient use.
Patient Sequence No: 1, Text Type: D, B5
[11885236]
(b)(4). The manufacturer has not yet received the device for evaluation. The unit will be evaluated once it has been received and a follow-up additional information report will be filed detailing the findings. Pma/510(k)# k061256.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00008 |
| MDR Report Key | 3802321 |
| Report Source | 05 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-01-23 |
| Date Mfgr Received | 2014-01-23 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-05-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRIS FERGUSON |
| Manufacturer Street | 191 WYNGATE DR |
| Manufacturer City | MONROEVILLE PA 15146 |
| Manufacturer Country | US |
| Manufacturer Postal | 15146 |
| Manufacturer Phone | 4123808804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 PS |
| Product Code | FLS |
| Date Received | 2014-02-21 |
| Model Number | 1014557 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS RESPIRONICS - CHMV |
| Manufacturer Address | 191 WYNGATE DRIVE MONROEVILLE PA 15146000 US 15146 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-21 |