SmartMonitor 2PSL w/ Modem 1028970Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B0361028970), received between Mar 6, 2018 and Nov 16, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  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 problems: No Known Impact Or Consequence To Patient

  MAUDE report 8080958 ↗
• MalfunctionAug 28, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  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 problems: No Known Impact Or Consequence To Patient

  MAUDE report 7824789 ↗
• MalfunctionMar 6, 2018Communication or Transmission Problem; Communication or Transmission Problem

  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 problems: No Consequences Or Impact To Patient

  MAUDE report 7318882 ↗

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 · Terminated
  SmartMonitor 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 · Terminated
  Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
• Z-1086-2008 · Oct 15, 2007 · Terminated
  APNEA 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