MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-25 for SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM 4003 manufactured by Philips Medical Systems.
[6262922]
Philips healthcare received a complaint from a durable medical equipment (dme) supplier stating that a smart monitor 2 infant apnea monitor was not alarming during test 2 of the checkout procedure, but it was alarming for the other steps. The device was not in use at the time of failure and no patient harm was alleged.
Patient Sequence No: 1, Text Type: D, B5
[13471112]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2015-03356 |
| MDR Report Key | 4868752 |
| Report Source | 08 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-10 |
| Date Mfgr Received | 2015-06-10 |
| Date Added to Maude | 2015-06-26 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2015-06-25 |
| Model Number | 4003 |
| Operator | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-25 |