MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-08 for SMARTMONITOR2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM 4003 manufactured by Philips Medical Systems.
[5145404]
Philips healthcare received a call from lifehme inc on (b)(6) 2014 stating that they would like to have their device tested/calibrated after a patient had passed away while on the device. The customer stated that the device did alarm as expected during the event and that there is no allegation of the device malfunctioning.
Patient Sequence No: 1, Text Type: D, B5
[12625256]
(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 information for subsequent clinical review. Due to a death being reported, philips healthcare has determined that the reported issue required further investigation. Philips healthcare received the device for evaluation. The unit was found to operate and alarm appropriately for simulated events. No observations substantiating a malfunction or other operation outside of design specifications were made during the evaluation. It is concluded that use of the device does not present an increased risk to the end user or patient and that no corrective action or additional investigation is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-07412 |
| MDR Report Key | 4345673 |
| Report Source | 06 |
| Date Received | 2014-12-08 |
| Date of Report | 2014-11-18 |
| Date Mfgr Received | 2014-11-18 |
| Date Added to Maude | 2014-12-22 |
| 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 018101099 |
| Manufacturer Country | US |
| Manufacturer Postal | 018101099 |
| Manufacturer Phone | 9786597429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM |
| Product Code | NPF |
| Date Received | 2014-12-08 |
| Returned To Mfg | 2014-11-20 |
| Model Number | 4003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 01810109 US 01810 1099 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-12-08 |