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 2018-04-06 for SMART MONITOR 2PS 1030271 manufactured by Circadiance, Llc.
[104845314]
The nurse call jack in this monitor was physically damaged rendering the output inoperable. Circadiance has recently re-evaluated reporting decisions related to physically damaged nurse call jacks. Circadiance has made the decision to report these instances of damaged nurse call jacks where the jack is still physically intact and it is possible that the user may have perceived that they were still able to make a connection to the jack. This complaint was received prior to the re-evaluation of reporting, however, the event occurred relatively recently. Thus circadiance has re-classified this complaint and has retrospectively filed this report to be consistent with the recent internal changes regarding reporting these events. The primary alarm in this monitor as well as all of the monitoring parameters were confirmed to be operating according to specification.
Patient Sequence No: 1, Text Type: N, H10
[104845315]
(b)(6) hospital sent a smart monitor 2ps model number 1030271, serial number (b)(4) in for service requesting that circadiance check the overall performance of the monitor. The customer did not allege that the product was malfunctioning. They just requested that the device be evaluated. During service evaluation, the service technician determined that the nurse call jack was partially dislodged from the main circuit board rendering the nurse call output nonfunctional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006182632-2018-00009 |
| MDR Report Key | 7402953 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-06 |
| Date of Report | 2018-03-28 |
| Date of Event | 2018-02-02 |
| Date Mfgr Received | 2018-01-30 |
| Device Manufacturer Date | 2009-10-16 |
| Date Added to Maude | 2018-04-06 |
| 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 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 | 2018-04-06 |
| Returned To Mfg | 2018-01-30 |
| Model Number | 1030271 |
| Catalog Number | 1030271 |
| 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 | 2018-04-06 |