NA PU-681RARecalls & reported problems

Summary

The FDA's MAUDE database contains 1,493 adverse event reports that list this exact device (DI 04931921131640), received between Mar 28, 2018 and Sep 30, 2026 — classified as 22 deaths, 1 injury, 1,470 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (433 reports).

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 25 most recent of 1,493 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Display/Image; Output Problem

  The Biomedical Engineer (BME) reported that the Central Nurse Station (CNS) was displaying a "No Video Present" message on all its monitors. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947454 ↗
• MalfunctionSep 29, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928004 ↗
• MalfunctionSep 25, 2026Computer Software Problem; Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50901690 ↗
• MalfunctionSep 21, 2026Electrical /Electronic Property Problem; Power Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843202 ↗
• MalfunctionSep 21, 2026Application Program Problem

  The Biomedical Engineer (BME) reported that the Central Nurse's Station (CNS) displayed a windows blue screen with MACHINE_CHECK_EXCEPTION error. The unit was powered off / on. It booted for approximately 20 seconds, began loading Windows, then displayed a second blue screen with a CLOCK_WATCHDOG_TIMEOUT error. They also noted that the fan at the bottom/rear of the tower did not appear to be spinning. Symptoms appear consistent with a hardware issue. Tech Support (TS) recommended sending the unit to the repair center for evaluation. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839478 ↗
• MalfunctionSep 21, 2026Application Program Problem; Unintended Application Program Shut Down

  The Biomedical Engineer (BME) reported that the Central Nurse's Station (CNS) spontaneously rebooted. Monitoring resumed after the reboot. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839477 ↗
• MalfunctionSep 21, 2026Application Program Problem

  The Biomedical Engineer (BME) reported that the Central Nurse's Station (CNS) went through a blue screen previously and believes the HDDs are failing. He is requesting to replace both hard drives. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839280 ↗
• MalfunctionSep 15, 2026Unintended Application Program Shut Down

  The Biomedical Engineer (BME) reported that the Central Nurse Station (CNS) unexpectedly powered down/rebooted, resulting in loss of historical patient data. No reports of patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772773 ↗
• MalfunctionSep 14, 2026Application Program Problem; Communication or Transmission Problem; Unintended Application Program Shut Down

  The Biomedical Engineer (BME) reported that the Central Nurse's Station (CNS) was originally displaying Comm Loss on all the tiles. He disconnected and reconnected the ethernet cable but that did not resolve the issue, so he rebooted the CNS. After rebooting the CNS, it began boot looping. He removed the CNS from service and replaced it with a spare unit. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755105 ↗
• MalfunctionSep 4, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611851 ↗
• MalfunctionSep 2, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568784 ↗
• MalfunctionSep 2, 2026No Display/Image; Display or Visual Feedback Problem; Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568069 ↗
• MalfunctionSep 2, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565010 ↗
• MalfunctionAug 28, 2026Erratic or Intermittent Display; Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50502644 ↗
• MalfunctionAug 24, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50407313 ↗
• MalfunctionAug 18, 2026Power Problem; Complete Loss of Power

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50308857 ↗
• MalfunctionAug 17, 2026Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286655 ↗
• MalfunctionAug 17, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279687 ↗
• MalfunctionAug 17, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50279450 ↗
• MalfunctionAug 17, 2026Application Program Problem; Unintended Application Program Shut Down

  The Biomedical Engineer (BME) reported that the Central Nurse's Station (CNS) has a blue screen and spontaneously reboots. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50277894 ↗
• MalfunctionAug 17, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50276846 ↗
• MalfunctionAug 12, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223624 ↗
• MalfunctionAug 12, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221272 ↗
• MalfunctionAug 11, 2026Application Program Problem; Unintended Application Program Shut Down

  The Biomedical Engineer (BME) reported that the Central Nurse's Station (CNS) was boot looping this had been going on for about 15 minutes before the call. The looping seemed to eventually stop but then the monitoring network disconnect message was displayed. Tech Support (TS) had them check then connections on both the CNS and the wall. Both connections seemed good and on the CNS side the green status led was lit. They were also able to confirm that the network cable was plugged into the correct port on the CNS. The unit rebooted again and was stuck in a bootloop. They have multiple NK ports. The BME swapped ports with another CNS, and the CNS eventually booted up into the application. TS asked the BME to pull the logs for this CNS. No patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202155 ↗
• MalfunctionAug 11, 2026Application Program Problem; Unintended Application Program Shut Down

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202101 ↗