MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-11-06 for SMARTMONITOR 2 4002 manufactured by Phillips Respironics - Chmv.
[20105027]
Children's medical ventures (chmv) received a report from a durable medical equipment (dme) supplier associated with a smart monitor 2 device. The report alleges the "unit shut down during exam. " the device was reportedly in use at the time of the reported event. However, no resulting effect on the patient has been reported. Multiple attempts to reach the dme for additional information and to have the device returned for evaluation have been made. This investigation is being conducted due to the fact that it is unk whether or not the device alarmed appropriately to notify a caregiver of a potential issue at the time of the reported event.
Patient Sequence No: 1, Text Type: D, B5
[20179939]
(b)(4). The complaint issue alleged by the customer was not able to be confirmed because the device was not returned to the mfr for evaluation. The smart/monitor 2 (sm2) is intended for use in continuous monitoring of heart rate and respiration of infant patients in a home, hospital, or portable environment. The sm2 receives physiological signals via transducers attached to the patient and directly connected to the monitor, or from devices connected to the auxiliary inputs of the monitor. Physiological signals (patient events) and equipment events are recorded in nonvolatile memory for subsequent review and analysis by a health care professional. During monitoring, when the patient's breathing effort and heart activity are not within the set boundaries, an indicator light comes on and an alarm sounds. The power source of the device at the time of the reported event is unk. However, if the device was being operated on battery power the device is designed to alarm to notify a care giver of the following scenarios: low batter waring batter voltage low, power supply required promptly. Low batter shutdown battery voltage too low to continue without power supply. Although the customer complaint allegation could not be substantiated, multiple methods of risk management have been incorporated into the design of the product that would notify a caregiver of a potential patient and/or product issue. Chmv has no reason to believe that the device did no perform to specification to notify a caregiver of a potential event. Quality assurance has concluded that no additional investigation into the reported issue is appropriate 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 will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007056120-2013-00019 |
| MDR Report Key | 3560866 |
| Report Source | 05 |
| Date Received | 2013-11-06 |
| Date of Report | 2013-10-07 |
| Date Mfgr Received | 2013-10-07 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2014-02-14 |
| 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 151460000 |
| Manufacturer Country | US |
| Manufacturer Postal | 151460000 |
| 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 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2013-11-06 |
| Model Number | 4002 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILLIPS RESPIRONICS - CHMV |
| Manufacturer Address | 191 WYNGATE DR MONROEVILLE PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-06 |