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 2018-11-26 for SMART MONITOR 2 4002 manufactured by Circadiance, Llc.
[128290340]
This monitor is the home version of the smart monitor 2 and the jack on the back of the monitor is for interfacing to a previously sold remote alarm for home use. This jack is not operable with a nurse call system. The user facility has been informed that this interface should not be used with a nurse call system as it is not intended for that purpose.
Patient Sequence No: 1, Text Type: N, H10
[128290341]
A user facility reported that the nurse call jack on the monitor was not functioning properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00028 |
| MDR Report Key | 8102283 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-26 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-11-01 |
| Date Mfgr Received | 2018-11-01 |
| Device Manufacturer Date | 2014-12-17 |
| Date Added to Maude | 2018-11-26 |
| 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 | 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 CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal | 15145 |
| Manufacturer Phone | 7243879836 |
| Manufacturer G1 | CIRCADIANCE |
| Manufacturer Street | 1300 RODI RD |
| Manufacturer City | TURTLE CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15145 |
| 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 | 2018-11-26 |
| Returned To Mfg | 2018-11-06 |
| Model Number | 4002 |
| Catalog Number | 4002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-26 |