MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-29 for SMART MONITOR 2 4003 manufactured by Circadiance, Llc.
[118574865]
The smart monitor 2 devices incorporate a start up sequence where all audible and visual alarm indicators are activated to allow a user to verify that all of these elements function correctly every time the monitor is turned on to be put into service. The device that is the subject of this report was not in patient use when the audible alarm failure was detected suggesting that the start up sequence does provide an appropriate means for the user to determine whether or not the monitor's alarm systems are functioning properly.
Patient Sequence No: 1, Text Type: N, H10
[118574866]
A user facility contacted circadiance on (b)(6) 2018 and reported that the audible alarm in the monitor was not functioning. The monitor was not being used with a patient when this issue was identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00024 |
| MDR Report Key | 7826643 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-08-03 |
| Date Mfgr Received | 2018-08-03 |
| Device Manufacturer Date | 2017-12-21 |
| Date Added to Maude | 2018-08-29 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RICHARD LORDO |
| Manufacturer Street | 1300 RODI RD |
| Manufacturer City | TURTLE CREEI PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal | 15145 |
| Manufacturer Phone | 7243879836 |
| Manufacturer G1 | FIRSTRONIC, LLC |
| Manufacturer Street | 1655 MICHIGAN ST NE |
| Manufacturer City | GRAND RAPIDS MI 49503 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49503 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 2 |
| Generic Name | INFANT APNEA MONITOR |
| Product Code | FLS |
| Date Received | 2018-08-29 |
| Returned To Mfg | 2018-08-07 |
| Model Number | 4003 |
| Catalog Number | 4003 |
| 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 | 1300 RODI RD TURTLE CREEK PA 15145 US 15145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-29 |