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 SMART MONITOR 2 PS 1014557 manufactured by Philips Respironics -chmv.
[4410185]
Children's medical ventures (chmv) received a complaint allegation of a product issue associated with a smart monitor 2 professional series (ps) device. The reported issue alleged that the devices alarm was low. The device was reportedly in patient use at the time of the alleged failure. However, there is no allegation of harm associated with the reported complaint issue.
Patient Sequence No: 1, Text Type: D, B5
[12062132]
(b)(4). The complaint issue alleged by the customer was not able to be confirmed because the device was not returned to the manufacture for evaluation. No unique device identifiers have been provided by the customer. Multiple attempts to reach the customer for additional information and to have the device returned for evaluation have been made. No additional information is available at this time. The smartmonitor 2ps is intended for use in the continuous monitoring of respiration, heart rate and spo 2 levels of infant, pediatric, and adult patients. It detects and alarms for periods of high or low heart rate, high or low breath rate, and high or low saturation. When used as an infant monitor it is intended for use in a home or hospital environment. For infants only, it monitors and alarms for central apneas. When used as a pediatric or adult monitor, it is intended for use in a hospital environment. 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. Based on a complete review of this complaint it is concluded that no further investigation into the alleged complaint issue is possible at this time. However, if the device in question is returned for investigation and it is concluded that a failure outside of the design specifications took place, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2014-00012 |
| MDR Report Key | 3853473 |
| Report Source | 05 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-03-06 |
| Date Mfgr Received | 2014-03-06 |
| 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, SR. AND RM |
| 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 | SMART MONITOR 2 PS |
| Product Code | FLS |
| Date Received | 2014-04-04 |
| Model Number | 1014557 |
| Device Availability | N |
| 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 | 2014-04-04 |