MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-12-10 for SMARTMONITOR 2 W/O MODEM 4002 manufactured by Circadiance, Llc.
[33113655]
Circadiance, (b)(4) received a customer complaint on (b)(6) 2015 where it was alleged that a smartmonitor 2 unit was not producing an audible alarm. The unit was sent back to circadiance, (b)(4). Upon inspection of the device, it was determined that the device was producing an audible alarm; however, the alarm sound was distorted. The customer stated that the device was in use at the time the problem was discovered and no patient or user harm was alleged or had occurred. The alarm module has been returned to the manufacturer for further investigation. Results of the investigation will be provided in a follow up report. 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 instructions and features notified the caregiver and subsequently returned the device for servicing.
Patient Sequence No: 1, Text Type: D, B5
[44727235]
Circadiance, llc has completed its investigation of the smartmonitor 2 product failure detailed in the initial medwatch submission. The investigation concluded that the identified issue could not be substantiated by the components manufacturer. Testing of the component concluded that it was found to operate and perform to specification. No operational issues signifying a malfunction were recorded during the manufacturer's investigation. The operator's manual recommends that before you use the smart monitor 2, test to see if you can hear the alarm in different rooms while there is noise in your house. The operator's manual recommends to always keep the area in front of the speaker clear and to turn the monitor on (without the child attached) to sound the alarm, making sure you can hear the alarm in different areas of your home. Circadiance has determined that based on a complete review of the available information, 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 activity is necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006182632-2015-00004 |
| MDR Report Key | 5284898 |
| Report Source | USER FACILITY |
| Date Received | 2015-12-10 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-11-06 |
| Date Mfgr Received | 2015-11-13 |
| Device Manufacturer Date | 2008-04-29 |
| Date Added to Maude | 2015-12-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES GIANOUTSOS |
| Manufacturer Street | 1060 CORPORATE LANE |
| Manufacturer City | EXPORT PA 15632 |
| Manufacturer Country | US |
| Manufacturer Postal | 15632 |
| Manufacturer Phone | 7243879182 |
| Manufacturer G1 | CIRCADIANCE, LLC |
| Manufacturer Street | 1060 CORPORATE LANE |
| Manufacturer City | EXPORT PA 15632 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15632 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTMONITOR 2 W/O MODEM |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-12-10 |
| Returned To Mfg | 2015-11-13 |
| Model Number | 4002 |
| Catalog Number | 4002 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCADIANCE, LLC |
| Manufacturer Address | 1060 CORPORATE LANE EXPORT PA 15632 US 15632 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-10 |