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 2018-02-15 for SMART MONITOR 2PS 1014557 manufactured by Circadiance, Llc.
[100434988]
Upon reviewing the nurse call jack it is obvious that the jack was physically damaged. The only plausible explanation for the level of damage see on the jack would be for the unit to have suffered an impact, such as being dropped, with the nurse call wye cable connected to the nurse call jack. I spoke with the complainant on 2/12/2018 and she could not provide any specific information regarding the damaged nurse call jack. She only indicated that nursing would send the unit to the biomedical department noting that the alarm port was not working. The exact mechanism that nursing used to determine that the port was not functional was not able to be ascertained. We are unsure if the damage was noticed when the unit was dropped or at some point in time after the damage had occurred. This failure of the nurse call jack does not compromise the ability of the monitor to monitor and detect alarm conditions. The primary alarm system in the monitor remained functional. The professional user manual clearly indicates that the nurse call feature is provided for convenience and should not be relied upon as the primary alarm system.
Patient Sequence No: 1, Text Type: N, H10
[100434989]
On (b)(6) 2018 the specialty hospital of (b)(6) returned a smart monitor 2ps infant apnea monitor model number 1014557 (serial number (b)(4)) with the complaint that the remote alarm port does not work. The circadiance service technician confirmed the complaint and documented that the nurse call jack is damaged. If the unit was used with the damaged nurse call jack, the monitor may not transmit an alarm to the hospital nurse call system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00003 |
| MDR Report Key | 7274410 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-15 |
| Date of Report | 2019-02-15 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2018-02-15 |
| 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 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR 2PS |
| Generic Name | INFANT APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2018-02-15 |
| Model Number | 1014557 |
| Catalog Number | 1014557 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CIRCADIANCE, LLC |
| Manufacturer Address | 1300 RODI ROAD TURTLE CREEK, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-15 |