MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-12 for SMART MONITOR 2 4003 manufactured by Circadiance Llc.
[52023255]
The complaint issue alleged by the customer was not able to be confirmed because the device has not been sent to circadiance for evaluation. The customer stated that the device will not be sent in for service and requested that the complaint record be closed. The smartmonitor 2 device has provisions to allow the user to detect failure of the audible alarm. Specifically, the users are instructed that the audible alarm will annunciate every time that the monitor is turned on allowing the user to verify alarm functionality prior to placing the device into service. Additionally, users are instructed to perform a full device checkout by following the published smartmonitor 2 checkout procedure between uses on different patients or at least annually if the monitor has not been in use. The steps of the checkout procedure fully verify all of the alarm functions of the smartmonitor 2. These instructions and features minimize the risk that an audible alarm failure can result in patient injury. The user of this equipment is responsible for reading, understanding, and following the warning and caution statements throughout the manual. No additional information is available at this time. If additional information becomes available or the device is sent to circadiance for evaluation, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[52023256]
Circadiance, llc received customer complaint allegation on (b)(6) 2016 detailing a product issue associated with a smartmonitor 2 device. The customer reported that the device failed to alarm during the functional self-test. No resulting effect on a patient or potential user has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2016-00003 |
| MDR Report Key | 5871605 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-08-12 |
| Date of Report | 2016-07-15 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2016-01-31 |
| Date Added to Maude | 2016-08-12 |
| 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 | 3 |
| Manufacturer Contact | MR. JAMES GIANOUTSOS |
| Manufacturer Street | 1300 RODI ROAD |
| Manufacturer City | TURTLE CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal | 15145 |
| Manufacturer Phone | 7243879182 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2016-08-12 |
| Model Number | 4003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCADIANCE LLC |
| Manufacturer Address | 1300 RODI ROAD TURTLE CREEK PA 15145 US 15145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-12 |