MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-30 for SMART MONITOR 2 4002 manufactured by Circadiance.
[118799184]
At this time, there is no evidence that the monitor caused or contributed to the reported fire and resultant caregiver injury. Circadiance is seeking an outside expert to further analyze the monitor to either corroborate or alter the conclusions derived from our internal analysis. Given that a documented caregiver injury was reported, circadiance has chosen to file an mdr report with the fda even though there is no indication that the monitor malfunctioned and/or caused or contributed to reported caregiver's injury.
Patient Sequence No: 1, Text Type: N, H10
[118799185]
(b)(6) contacted circadiance to report that a smart monitor 2 infant apnea monitor and an oxygen cylinder had been involved in a "flash fire". The following text is copied from the submission form received from (b)(6): "this devise (sic) was used at the same time an oxygen tank emitted a flash fire. The mothers (sic) foot was burned no injury to the child or anyone else. The apnea monitor continued to work without interruption. Please do a full investigation of equipment with a detailed report of the functionality of apnea monitor. " a follow up call to (b)(6) revealed that the patient's mother experienced a second degree burn on her foot and required treatment at a hospital. Circadiance is not aware of whether or not the mother was admitted to the hospital or if treatment was administered in the emergency department. There is no reported injury to the infant patient as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00023 |
| MDR Report Key | 7833862 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-30 |
| Date of Report | 2018-07-05 |
| Date of Event | 2018-06-23 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2012-09-26 |
| Date Added to Maude | 2018-08-30 |
| 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 |
| 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, LLC |
| Manufacturer Street | 1300 RODI RD. |
| Manufacturer City | TURTLE CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15145 |
| Single Use | 3 |
| Remedial Action | RL |
| 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 | 2018-08-30 |
| Returned To Mfg | 2018-06-27 |
| Model Number | 4002 |
| Catalog Number | 4002 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCADIANCE |
| Manufacturer Address | 1300 RODI RD. TURTLE CREEK PA 15145 US 15145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-30 |