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 2018-03-06 for SMART MONITOR 2PSL 1028970 manufactured by .
[101864466]
Circadiance was not able to replicate the customer's complaint. The nurse call output was found to be working properly. A follow up phone call with the customer was made to discuss the issue to determine if any other aspects of the installation might have impacted the alarm signal transmission. The customer described a connection between their nurse call system and the monitor that seemed to be appropriate. During the conversation, the customer was asked to test the monitor when it is received back from circadiance to verify that they agree that the monitor is working as intended. The customer was also asked to test multiple interface cables at their site to see if an interface cable may be malfunctioning. Circadiance has chosen to report this incident since the actual cause of the failure to transmit the alarm has not been determined. If the customer provides follow up information regarding testing with interface cables in their facility, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[101864467]
Saint francis health system reported that a smart monitor 2ps, model number 1028970, serial number (b)(4) had an auxilliary alarm interface that was not working. The biomed reported that staff informed biomed that the alarm would not call the desk through the nurse call system. The biomed reported that she visited the location where the monitor was used and verified that alarms were not being transmitted to through the nurse call system. The biomed also reported that the primary alarm in the monitor was working.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00008 |
| MDR Report Key | 7318882 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-06 |
| Date of Report | 2018-03-06 |
| Date Mfgr Received | 2018-02-06 |
| Device Manufacturer Date | 2017-06-25 |
| Date Added to Maude | 2018-03-06 |
| 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 |
| Single Use | 3 |
| 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 | 2018-03-06 |
| Returned To Mfg | 2018-02-13 |
| Model Number | 1028970 |
| Catalog Number | 1028970 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-06 |