MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-04 for SMARTMONITOR 2 4003 manufactured by Philips Respironics - Chmv.
[4620612]
Children's medical ventures (chmv) received a complaint allegation of a product issue associated with a smart monitor 2 device. The reported issue alleged that the device was running for a little bit and then shuts off. The device was reportedly not in patient use at the time of the alleged failure. There is no allegation of harm associated with the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5
[12062413]
(b)(4). The complaint issue alleged by the customer was confirmed during the repair evaluation of the device at the manufacturer's service center and associated with a faulty main pca board. The device turned on and went through the power up diagnostic. The device ran for approximately 15 seconds and then shut down without alarming. The smartmonitor 2 device is designed to monitor respiration, heart rate. Upon detection of abnormal events, smartmonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review. Quality assurance has determined that further investigation into the recorded failure is necessary. A follow-up report will be submitted detailing the conclusions of the product investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00011 |
| MDR Report Key | 3853462 |
| Report Source | 05 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-03-05 |
| Date Mfgr Received | 2014-03-05 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2014-06-20 |
| 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 | 12151 RESEARCH PARKWAY, SUITE 200 |
| 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 | 2014-04-04 |
| Returned To Mfg | 2014-03-10 |
| Model Number | 4003 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-04-04 |