SmartMonitor 2PS w/ Modem 1014557Recalls & reported problems
Circadiance, LLC · SmartMonitor 2PS w/ Modem · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI B0361014557), received between Feb 15, 2018 and May 4, 2018 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 reports).
3 other recalls cover devices cleared under the same FDA submission (K061256); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated18
Patient problems
- No Consequences Or Impact To Patient18
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488755 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018 THE SPECIALTY HOSPITAL OF (B)(6) (A.K.A. (B)(6) HOSPITAL) RETURNED A SMART MONITOR 2PS INFANT APNEA MONITOR MODEL NUMBER 1014557 (SERIAL NUMBER) 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488753 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON APRIL 6, 2018 (B)(6) 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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488751 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
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 problems: No Consequences Or Impact To Patient
MAUDE report 7488750 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON APRIL 6, 2018 (B)(6) RETURNED A SMART MONITOR 2PS INFANT APNEA MONITOR MODEL NUMBER (B)(4) (SERIAL NUMBER) 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488749 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018 THE SPECIALTY HOSPITAL OF (B)(6) (A.K.A. (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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488747 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON APRIL 6, 2018 (B)(6) 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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488746 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488744 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018 THE SPECIALTY HOSPITAL OF (B)(6) (A.K.A. (B)(6) COMMUNITY 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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488742 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON APRIL 6, 2018 (B)(6) 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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7488741 ↗MalfunctionMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
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 problems: No Consequences Or Impact To Patient
MAUDE report 7488740 ↗MalfunctionFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018, (B)(6) 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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274419 ↗MalfunctionFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON JANUARY 19, 2018 THE (B)(6) HOSPITAL OF (B)(6) RETURNED A SMART MONITOR 2PS INFANT APNEA MONITOR MODEL NUMBER 1014557 (SERIAL (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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274415 ↗MalfunctionFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018, (B)(6) 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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274414 ↗MalfunctionFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018 THE SPECIALTY HOSPITAL OF (B)(6) 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 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
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274412 ↗MalfunctionFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018 THE (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 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. DEVICE WAS EVALUATED BY CIRCADIANCE SERVICE ON 1/29/2018. THE DEVICE WAS FOUND TO HAVE A MECHANICALLY DAMAGED NURSE CALL JACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274411 ↗MalfunctionFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018 THE SPECIALTY HOSPITAL OF (B)(6) 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 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.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7274410 ↗MalfunctionFeb 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
ON (B)(6) 2018 THE SPECIALTY HOSPITAL OF (B)(6) (A.K.A. (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 problems: No Consequences Or Impact To Patient
MAUDE report 7273925 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K061256. One submission often covers many models, so check the product and lot details in each record.
- Z-2250-2017 · May 1, 2017 · TerminatedSmartMonitor 2 PS/PSL, Monitor, Apnea, Facility USE. Intended for use in the continuous monitoring of respiration, heart rate, and SP02 of infant, pediatric and adult patients.
- Z-1789-2014 · Apr 29, 2014 · TerminatedPhilips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
- Z-1086-2008 · Oct 15, 2007 · TerminatedAPNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422; b) SM 2/2 PS Europe Patient Cable, Metal model number
Other Monitor, Apnea, Home Use devices
- SmartMonitor 2PSL w/ Modem 1028970Circadiance, LLC · Monitor, Apnea, Home Use3 reports
- SmartMonitor 2PS Hospital Alarm 1030271Circadiance, LLC · Monitor, Apnea, Home Use1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page