Puritan Bennett 4-840220NISB-ENRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521077201), received between Mar 28, 2017 and Aug 23, 2021 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (5 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. 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2021Smoking; Smoking

  IT WAS REPORTED THAT WHILE IN USE ON A PEDIATRIC PATIENT, SMOKE WAS NOTED COMING FROM THE CAPACITOR OF THE AIR COMPRESSOR OF THIS 840 VENTILATOR. PATIENT OUTCOME IS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354398 ↗
• MalfunctionOct 3, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE THE 840 VENTILATOR SCREEN WAS "FLICKERING" AND THE VENTILATOR STOPPED VENTILATION. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929740 ↗
• MalfunctionSep 13, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE THE 840 VENTILATOR STOPPED WORKING AND STARTED ALARMING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM OR INJURY AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 7875704 ↗
• MalfunctionFeb 13, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT DURING USE, THE 840 VENTILATOR GENERATED A DEVICE ALERT AND STOPPED WORKING. THE PATIENT'S OXYGEN SATURATION DROPPED FROM 94% TO 86%. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT WAS TRANSFERRED OR THE PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 7266849 ↗
• MalfunctionJan 8, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE 840 VENTILATOR ALARMED WITH A PATIENT DISCONNECT WHEN POWERED ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7172208 ↗
• MalfunctionAug 18, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A BLANK DISPLAY DURING THE POWER ON SELF TEST. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE ISSUE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND THE BACKLIGHT INVERTER PCB¿S WERE UPDATED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6805783 ↗
• MalfunctionAug 18, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A DAMAGED POWER SUPPLY. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE BACK UP POWER SOURCE BOARD TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6805519 ↗
• MalfunctionAug 10, 2017Power Problem; Power Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD LOSS OF ALTERNATING CURRENT (AC) POWER. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6786575 ↗
• MalfunctionAug 2, 2017Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A BREATH DELIVERY (BD) POWER ON SELF-TEST (POST) FAILURE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE ISSUE AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6760319 ↗
• MalfunctionAug 2, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A BLANK DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 6760012 ↗
• MalfunctionJul 31, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR DISPLAYED A YELLOW BANNER ALARM INDICATING A BATTERY ISSUE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE BATTERY BOARD BPS (BACK UP POWER SOURCE) BOARD TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6755394 ↗
• MalfunctionJul 21, 2017Battery Problem; Battery Problem

  IT WAS REPORTED AN 840 VENTILATOR HAD A FAULTY BATTERY. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME. THE SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE BPS, PCB, (BACKUP POWER SUPPLY, PRINTED CIRCUIT BOARD). THE SERVICE ENGINEER RAN AN EXTENDED SELF TEST (EST) AND A SHORT SELF TEST (SST) AND UNIT PASSED ALL TESTS.

  Patient problems: No Information

  MAUDE report 6733570 ↗
• InjuryJul 21, 2017Device Alarm System; Device Alarm System

  IT WAS REPORTED WHILE IN USE ON A PATIENT AN 840 VENTILATOR WAS GENERATING AN ALARM INTERMITTENTLY AND SHOWING HIGH RATIO ALARM LIMITS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THIS EVENT. THE SERVICE ENGINEER WAS UNABLE TO DUPLICATE THE REPORTED CONDITION. SERVICE ENGINEER RAN CALIBRATIONS, EXTENDED SELF TEST (EST), SHORT SELF TEST (SST), PERFORMANCE VERIFICATION TEST (PVT) AND ELECTRICAL SAFETY TEST AND DEVICE PASSED ALL TESTING.

  Patient problems: No Code Available

  MAUDE report 6732079 ↗
• InjuryJun 30, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE, AN 840 VENTILATOR HAD A LEAK. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND DIAGNOSTIC CODES RELEVANT TO THE REPORTED ISSUE BUT WAS UNABLE TO DUPLICATE THE REPORTED CONDITION. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Code Available

  MAUDE report 6682407 ↗
• MalfunctionJun 4, 2017No Display/Image; No Display/Image

  INFORMATION WAS RECEIVED INDICATING THAT, AN 840 VENTILATOR HAD A FAULTY GRAPHICAL USER INTERFACE (GUI) DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 6610346 ↗
• MalfunctionJun 1, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD THE GUI CABLE (GRAPHICAL USER INTERFACE) REPLACED DUE TO DAMAGE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER (SE) REPLACED GUI CABLE TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6606994 ↗
• InjuryMay 25, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT, DURING USE ON A PATIENT AN 840 VENTILATOR WAS TURN ON AND OFF INTERMITTENTLY. PATIENT OUTCOME WAS NOT PROVIDED. THE SERVICE ENGINEER (SE) VERIFIED THE EVENT IN THE MEMORY LOGS BUT THE SE WAS NOT ABLE TO DUPLICATE THE ALLEGED ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591696 ↗
• InjuryMay 18, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED, WHILE IN USE ON A PATIENT, AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. VERTICAL LINES WERE APPEARING ON THE TOP PANEL OF DISPLAY. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED PROBLEM. THE FSE REPLACED THE GRAPHICAL USER INTERFACE, CENTRAL PROCESSING UNIT, (GUI CPU) AND REPROGRAMMED THE SOFTWARE. FULL TESTING WAS COMPLETED.

  Patient problems: No Code Available

  MAUDE report 6577305 ↗
• MalfunctionMay 18, 2017Device Alarm System; No Display/Image; Device Alarm System; No Display/Image

  IT WAS REPORTED BY THE CUSTOMER THAT AN 840 VENTILATOR HAD A CONSTANT ALARM AND GUI (GRAPHICAL USER INTERFACE) RED LIGHT INDICATOR LIT ON BDU. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE TECHNICIAN REPLACED THE GUI TO BDU (BREATH DELIVERY UNIT) CABLE, PERFORMED CALIBRATIONS ALL TESTING PASSED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 6575884 ↗
• MalfunctionApr 20, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE 840 VENTILATOR FAILED EXTENDED SELF-TESTING (EST) DUE TO A FAILED BATTERY TEST. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A COVIDIEN FIELD SERVICE ENGINEER (FSE) INSPECTED THE DEVICE AND REPLACED THE BACK-UP POWER SOURCE (BPS) PRINTED CIRCUIT BOARD (PCB). THE FSE PERFORMED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6508826 ↗
• InjuryMar 31, 2017Disconnection; Disconnection

  IT WAS REPORTED THAT, AN 840 VENTILATOR WAS ALARMING WITH PATIENT DISCONNECT MESSAGE WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. CUSTOMER REPORTED THAT THE VENTILATOR HAD FAILED EXTENDED SELF TEST (EST) THIS WAS AFTER THE PATIENT EVENT. (FAILED FIRST EST DUE TO BEING RUN WITH PATIENT CIRCUIT ). RAN EST, SST (SHORT SELF TEST), SET UP FOR PATIENT AND GOT RE-CONNECTION AS NORMAL, UNABLE TO DUPLICATE THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6450787 ↗
• MalfunctionMar 28, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS A FAULTY LIQUID CRYSTAL DISPLAY. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. THE COMPLAINT WILL BE CLOSED AND REOPENED/UPDATED SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND TRENDS WILL CONTINUE TO BE MONITORED. A CAPA IS NOT REQUIRED AT THIS TIME.

  Patient problems: No Information

  MAUDE report 6440433 ↗