MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-08 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM 4003 manufactured by Philips Medical Systems.
[5619228]
Philips healthcare received a complaint from a durable medical equipment (dme) supplier stating that a patient was having? Episodes? That the device did not pick up. The dme did not describe the patient? S? Episodes? And no harm or lasting impact was alleged. The smart monitor 2 device is designed to monitor respiration, and heart rate. Upon detection of abnormal events, smart monitor 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
[13274785]
Based on a complete review of the complaint allegation, philips healthcare has determined that the reported issue requires further investigation. Once the device is returned for investigation or additional information is received, a follow-up additional information report will be filed to detail the findings and the need for any possible further action.
Patient Sequence No: 1, Text Type: N, H10
[13377347]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2015-01972 |
| MDR Report Key | 4669019 |
| Report Source | 05,06 |
| Date Received | 2015-04-08 |
| Date of Report | 2015-03-12 |
| Date Mfgr Received | 2015-03-12 |
| Date Added to Maude | 2015-04-29 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | MRS. WENDY CHADBOURNE |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-04-08 |
| Returned To Mfg | 2015-04-07 |
| Model Number | 4003 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | R |
| 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 ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-08 |