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 2018-11-16 for SMART MONITOR 2PSL 1028970 manufactured by Circadiance, Llc.
[127870584]
Circadiance has chosen to report instances of nurse call jacks that are damaged but still remain mechanically intact to the point where a user would be able to make a physical connection to the nurse call jack. If the user did not verify that the connection to the nurse call system was made, the user facility personnel may rely on the nurse call alarm versus relying on the integral alarm in the monitor to decide when to act. This would be an unexpected action given that this would mean that trained medical staff would ignore a primary device alarm and only respond to alarms at a nurse call station.
Patient Sequence No: 1, Text Type: N, H10
[127870585]
A user facility reported that "alarm connector broken inside alarm port" occurred on a smart monitor 2psl monitor, model 1028970, serial number (b)(4). The alarm port referred to by the customer in this complaint is a female jack that allows the monitor to be connected to a hospital nurse call system. In this case, the alarm port connections have been determined to be physically broken at the point where the jack is attached to the main circuit board. At least one of the connections is still intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00026 |
| MDR Report Key | 8080958 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-16 |
| Date of Report | 2018-08-28 |
| Date Mfgr Received | 2018-08-13 |
| Device Manufacturer Date | 2015-06-15 |
| Date Added to Maude | 2018-11-16 |
| 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 2PSL |
| Generic Name | INFANT APNEA MONITOR |
| Product Code | NPF |
| Date Received | 2018-11-16 |
| Model Number | 1028970 |
| Catalog Number | 1028970 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-11-16 |