MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-11 for SMARTMONITOR 2 4002 manufactured by Circadiance Llc.
[23938734]
The alarm module has been returned to the manufacturer for analysis. Results of that analysis 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 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.
Patient Sequence No: 1, Text Type: N, H10
[23938735]
Circadiance, llc received a customer complaint on (b)(6) 2915 where it was alleged that a smartmonitor 2 unit was not producing an audile alarming. The unit was sent back to circadiance. Upon inspection of the device, it was determined that the device was not producing an audible alarm. A circadiance representative contacted the customer to get additional details. The customer did not know if the device was in use at the time the problem was discovered and no patient harm was alleged.
Patient Sequence No: 1, Text Type: D, B5
[42292146]
Circadiance, llc has completed its investigation of the smartmonitor 2 device. The investigation concluded that the identified issue was associated with a quality manufacturing issue previously identified by the supplier of the component. The supplier had implemented a corrective action associated with this failure and determined that the corrective action was effective. The failure of the device had been previously identified in the product's risk analysis and product labeling. An evaluation of the risk associated with the identified failure has determined that there is no new or increased risk to the patient or user and that no additional risk reduction is necessary. Based on a complete review of the complaint allegation and the supplier's corrective action, it has been concluded that the identified failure is not considered to be a systemic issue and that the associated risk has been found to be acceptable. Complaint tracking and trending will continue to be monitored on a periodic basis. Circadiance, llc has determined that no further investigation or action is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006182632-2015-00001 |
| MDR Report Key | 5018686 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-06-29 |
| Date Mfgr Received | 2015-07-15 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2015-08-20 |
| 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 | 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 | SMARTMONITOR 2 |
| Generic Name | APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2015-08-11 |
| Returned To Mfg | 2015-07-20 |
| Model Number | 4002 |
| Catalog Number | 4002 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-08-11 |