MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-07 for SMARTMONITOR 2 4003 manufactured by Philips Respironics -chmv.
[4500819]
Children's medical ventures (chmv) received a report from (b)(6) stating that a smart monitor 2 infant apnea monitor failing simulation test. The device was not in pt use, the alleged failure was recorded during testing. The dme stated that the device has not yet been sent in for evaluation and it is unk if the device will be returned. No additional info is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[11893801]
(b)(4). The smartmonitor 2 device is designed to monitor respiration and heart rate. Upon detection of abnormal events, smartmonitor 2 alerts the caregiver via both visual and audible alarms and records the info for subsequent clinical review. Based on a complete review of the available info it is concluded that the complaint allegation could not be substantiated. If the unit is returned for investigation or if further info is received, an additional info, followup report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00009 |
| MDR Report Key | 3831975 |
| Report Source | 05 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-02-06 |
| Date Mfgr Received | 2014-02-06 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2014-06-13 |
| 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 | RUSTY KELLY |
| Manufacturer Street | 12501 RESEARCH PARKWAY |
| Manufacturer City | ORLANDO FL 32826 |
| Manufacturer Country | US |
| Manufacturer Postal | 32826 |
| Manufacturer Phone | 4074556166 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NO |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 |
| Product Code | FLS |
| Date Received | 2014-03-07 |
| Model Number | 4003 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS -CHMV |
| Manufacturer Address | 191 WYNGATE DR MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-07 |