MAUDE Adverse Event Report: CIRCADIANCE, LLC SMART MONITOR 2PS; INFANT APNEA MONITOR

Model Number	1014557
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 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 complainant had previously indicated that they had accumulated a number of monitors over time where the nurse call jack 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 (b)(6) 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 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.
Event or Problem Description
On april 6, 2018 (b)(6) returned a smart monitor 2ps infant apnea monitor model number 1014557 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.

• Brand Name: SMART MONITOR 2PS
• Common Device Name: INFANT APNEA MONITOR
• Manufacturer (Section D): CIRCADIANCE, LLC; 1300 rodi rd; turtle creek PA 15145
• MDR Report Key: 7488744
• Report Number: 3006182632-2018-00019
• Device Sequence Number: 2156457
• Product Code: NPF
• UDI-Device Identifier: B0361014557
• UDI-Public: B0361014557
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K061256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1014557
• Device Catalogue Number: 1014557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 05/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO