SmartMonitor 2PS Hospital Alarm 1030271Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B0361030271), received between Apr 6, 2018 and Apr 6, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (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 problems: No Consequences Or Impact To Patient

  MAUDE report 7402953 ↗

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