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 2PS 1014557 manufactured by Circadiance, Llc.
[108003511]
Upon reviewing the nurse call (b)(6) it is obvious that the (b)(6) was physically damaged. The only plausible explanation for the level of damage see on the (b)(6) 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 (b)(6). This complainant had returned another batch of monitors in (b)(6) 2018 for the same issue. I spoke with the complainant on (b)(6) 2018 during investigation of the previous complaints and she could not provide any specific information regarding the damaged nurse call (b)(6). 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 complainant had previously indicated that they had accumulated a number of monitors over time where the nurse call (b)(6) had been damaged and had just recently decided to start having the devices repaired and that is the reason for receiving the monitors in batches. This is not indicative of a group of simultaneous failures. Circadiance advised the customer at the time of the february complaints that they should investigate how these monitors are being handled in the hospital as this type of failure is unusual and their facility had experienced a disproportionately large incidence of this type of physical damage. This failure of the nurse call (b)(6) 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
[108003512]
On (b)(6) 2018 the specialty hospital of (b)(6) ((b)(6) hospital) 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 (b)(6) is damaged. If the unit was used with the damaged nurse call (b)(6), the monitor may not transmit an alarm to the hospital nurse call system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00022 |
| MDR Report Key | 7488750 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-04 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2013-01-16 |
| 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 RD. |
| Manufacturer City | TURTLE CREEK PA 15145 |
| Manufacturer Country | US |
| Manufacturer Postal | 15145 |
| Manufacturer Phone | 7243879836 |
| Manufacturer G1 | CIRCDADIANCE, LLC |
| 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 2PS |
| Generic Name | INFANT APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2018-05-04 |
| Returned To Mfg | 2018-04-25 |
| Model Number | 1014557 |
| Catalog Number | 1014557 |
| 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 RD. TURTLE CREEK PA 15145 US 15145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-04 |