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 2018-05-04 for SMART MONITOR 2 4003 manufactured by Circadiance, Llc.
[107338763]
As of the date of this investigation, circadiance has not been able to determine the medical reason for the patient "turning blue". As such, circadiance has decided to classify this event as a reportable event to the fda even though there is no evidence that the monitor in question was malfunctioning as we are not able to determine if the reported "failure to alarm" was in fact related to the monitor or a patient condition that is not detectable by the monitor such as an airway obstruction.
Patient Sequence No: 1, Text Type: N, H10
[107338764]
Infant was reported to have been monitored by the device in question. The parents reported to the durable medical equipment provider that the baby was found blue and the monitor was not alarming. The patient was transported to the hospital and admitted. There was no permanent injury reported to circadiance and the patient was reported to have been discharged back home the day after admission.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00010 |
| MDR Report Key | 7486197 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-04 |
| Date of Report | 2018-05-03 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2002-08-06 |
| Date Added to Maude | 2018-05-04 |
| 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 ROAD |
| Manufacturer City | TURTLE CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal | 15145 |
| Manufacturer Phone | 7243879836 |
| Manufacturer G1 | CIRCADIANCE, LLC |
| Manufacturer Street | 1300 RODI ROAD |
| Manufacturer City | TURTLE CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15145 |
| Single Use | 3 |
| 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 | 2018-05-04 |
| Returned To Mfg | 2018-04-19 |
| Model Number | 4003 |
| Catalog Number | 4003 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 1. Hospitalization | 2018-05-04 |