MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-20 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODERN 4003 manufactured by Philips Medical Systems.
[21087833]
Philips healthcare received a complaint from (b)(6) stating that an infant apnea monitor failed to alarm while on a patient. The patient was transported to hospital on (b)(6) 2014 and discharged on (b)(6) 2014. There is no lasting impact alleged. 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 information for subsequent clinical review.
Patient Sequence No: 1, Text Type: D, B5
[21219003]
(b)(4). Philips healthcare received a complaint from (b)(6) , a durable medical equipment (dme) supplier. The patient's father reported to dme that, on (b)(6) 2014, the patient was not breathing and that the device (an infant apnea monitor) failed to alarm while on the patient. The patient's father reported to the dme that he performed cpr, called 911 and the patient was transported to hospital. The patient was discharged from the hospital on (b)(6) 2014. There was no lasting patient impact alleged. Philips healthcare received the device for evaluation. The device was found to operate and alarm appropriately for simulated events. The device's memory data was downloaded and analyzed by the device manufacturer. The downloaded memory revealed that the device was set up with prescribed settings of a 20 second delay before triggering an apnea alarm and an 18 second delay before initiating a recording an alarm for apnea condition. The device was programmed with parameters that were appropriate for recording and alarming for respiration and heart rate during infant monitoring. The device's settings are prescribed by the patient's doctor and are input into the device by the dme. The device settings cannot be accessed or changed by the patient or the patient's family. The monitor's memory data download was found to show the unit alarmed multiple times (7) for bradycardia events on the day in question, (b)(6) 2014. No observations substantiating a malfunction or other operation outside of design specifications were made during the device evaluation. The device was found to operate and alarm within specifications to notify a caregiver of a potential event. The following observations were noted from the data downloaded from the device: the monitor had been in continuous use for the entire day of (b)(6) 2014 up until 7:54:30 pm. When the monitor was turned off. There were no loose lead events recorded on (b)(6) 2014 indicating that the monitoring electrodes had remained attached to the patient for the entire time that the monitor was in use on (b)(6) 2014. A review of the 7 bradycardia events (there were only 7 events recorded on (b)(6) 2014) that were recorded on (b)(6) 2014 shows clearly detectable r-wave peaks and a relatively clean ecg tracing. The respiration tracing also is clean. This observation suggests that there is proper lead contact and placement on the patient on the day in question and no evidence of external noise present. Based on the review of the waveforms as indicated above and the fact that the monitor passed all of the testing specified in the checkout procedure for the monitor, there is no indication that the monitor is not working as intended. The smart monitor 2 infant apnea monitors respiration via impedance plethysmography. Impedance monitors measure movement of the chest wall and, as such, are capable of detecting a central apnea where there is no chest wall movement as respiratory drive is suppressed during a central apnea. If a patient experiences an obstructive apnea, an impedance monitor will not detect this event. This is because there is chest wall movement as the patient is attempting to breathe. In this case, the monitor will sense this as a non-apneic event and therefore not initiate an alarm. The device's operator's manual provides information to the user indicating that obstructive apnea may not be detected by the monitor. It is not known if the patient in this report experienced an obstructive apnea.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2015-00102 |
| MDR Report Key | 4444737 |
| Report Source | 06 |
| Date Received | 2015-01-20 |
| Date of Report | 2014-12-17 |
| Date of Event | 2014-12-10 |
| Date Mfgr Received | 2014-12-17 |
| Date Added to Maude | 2015-01-26 |
| 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 | NANCY ATAIDE |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODERN |
| Product Code | NPF |
| Date Received | 2015-01-20 |
| Model Number | 4003 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-01-20 |