Puritan Bennett 4-840220DRAC-GRRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521077188), received between Mar 15, 2017 and Jun 1, 2021 — classified as 2 injuries, 25 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2021Smoking; Smoking

  IT WAS REPORTED THAT THE DISPLAY ON THIS 840 VENTILATOR FAILED, SMOKE WAS OBSERVED AND THE DEVICE GENERATED A CONTINUOUS, STEADILY LOUDER ALARM TONE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913781 ↗
• MalfunctionNov 10, 2020No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A SYSTEM ERROR MESSAGE. IT WAS ALSO REPORTED THAT THE UNIT FAILED AND VENTILATION DID NOT TAKE PLACE. THE PATIENT WAS REMOVED FROM THE VENTILATOR, AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY. THIS EVENT IS BEING CONSERVATIVELY FILED AS CUSTOMER REPORTED THAT THERE WAS A LOSS OF VENTILATION DURING THE EVENT, HOWEVER, THERE IS NO EVIDENCE FROM THE CODES REPORTED, OR SERVICE MANUAL DOCUMENTATION ON THE CODES THAT THE VENTILATOR WOULD HAVE STOPPED VENTILATION DURING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10820395 ↗
• MalfunctionFeb 3, 2020Smoking; Smoking

  IT WAS REPORTED THAT THE 840 VENTILATOR HAD POWER SUPPLY ISSUE ¿POPS AND SMOKES FROM THE BACK, FUSE JUMPED OUT.¿ THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9659604 ↗
• MalfunctionDec 13, 2019Smoking; Smoking

  IT WAS REPORTED THAT SPARKS CAME OUT OF THE 840 VENTILATOR AND A BURNING SMELL. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9469764 ↗
• MalfunctionMay 22, 2019No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A RED ALARM AND STOPPED DELIVERING BREATHS TO THE PATIENT. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8634572 ↗
• MalfunctionJul 5, 2018Failure To Run On AC/DC; Failure To Run On AC/DC

  IT WAS REPORTED THAT AN 840 VENTILATOR GENERATED VENTILATOR INOPERABLE ERROR CODES. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7664899 ↗
• MalfunctionJul 2, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT DURING PATIENT USE, THE PB840 VENTILATOR EXPERIENCED AN AUDIBLE AND VISUAL ALARM AND STOPPED VENTILATION. THE VENTILATOR GENERATED AN ERROR CODE IN THE MEMORY INDICATING AN UNEXPECTED HARDWARE SIGNAL. ACCORDING TO THE VENTILATOR LOGS, GUI (GRAPHIC USER INTERFACE) CENTRAL PROCESSING UNIT (CPU) SOFTWARE STOPPED COMMUNICATING WITH THE BD (BREATH DELIVERY) AN ERROR CODE WAS LOGGED. THE CONDITION PERSISTED CAUSING A GUI (GRAPHIC USER INTERFACE) POST (POWER ON SELF TEST) TO FAIL. 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 REPORTED EVENT. THIS EVENT IS BEING CONSERVATIVELY REPORTED AS THE FIELD SERVICE ENGINEER REPORTED THAT THERE WAS A LOSS OF VENTILATION DURING THE EVENT; HOWEVER, THERE IS NO EVIDENCE FROM THE CODES REPORTED, SERVICE MANUAL DOCUMENTATION ON THE CODE OR THE REPAIR PERFORMED THAT VENTILATOR WOULD HAVE STOPPED VENTILATION DURING THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 7656867 ↗
• MalfunctionAug 10, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN 840 VENTILATOR'S GRAPHICAL USER INTERFACE (GUI) BECAME INOPERATIVE. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE GUI PRINTED CIRCUIT BOARD (PCB) AND UPDATED THE BACKLIGHT INVERTER PCBS TO ADDRESS THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6786901 ↗
• MalfunctionAug 7, 2017No Display/Image; No Display/Image

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

  Patient problems: No Information

  MAUDE report 6771309 ↗
• MalfunctionJul 31, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED AN 840 VENTILATOR HAD A FAULTY DISPLAY. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. THE SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE GUI (GRAPHICAL USER INTERFACE) CPU (CENTRAL PROCESSING UNIT) AND BACK LIGHT INVERTER BOARDS. THE VENTILATOR PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER'S SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6755478 ↗
• MalfunctionJul 17, 2017Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE, AN 840 VENTILATOR HAD A FAULTY OXYGEN SENSOR (O2); IT HAD AN ISSUE WITH O2 MONITORING. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. THE UNIT PASSED TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS

  Patient problems: No Code Available; No Information

  MAUDE report 6719189 ↗
• MalfunctionJun 8, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A TOUCH SCREEN BLOCKED ERRORS. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED EVENT. NO PARTS WERE REPLACED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6628966 ↗
• MalfunctionJun 8, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY FROM AN 840 VENTILATOR WAS UNABLE TO HOLD THE CHARGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR AND VERIFIED THE CUSTOMER REPORTED ISSUE. THE SE REPLACED THE BATTERY AND THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6622306 ↗
• MalfunctionJun 7, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), THE BACKLIGHT INVERTER PCB¿S WERE UPGRADED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6617316 ↗
• InjuryJun 6, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A FAULTY DISPLAY, THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE FIELD SERVICE ENGINEER WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6616701 ↗
• MalfunctionJun 2, 2017No Display/Image; No Display/Image

  A GRAPHICAL USER INTERFACE PRINTED CIRCUIT BOARD (PCB) WAS RETURNED TO COVIDIEN/MEDTRONIC¿S FAILURE ANALYSIS. A VISUAL INSPECTION FOUND NO NOTABLE CONDITIONS. AN INVESTIGATION WAS PERFORMED AND THE IDENTIFIED ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A COMPONENT (VIDEO GRAPHICS ARRAY CONTROLLER U63) ON THE XENA I PCB.

  Patient problems: No Patient Involvement

  MAUDE report 6608436 ↗
• MalfunctionMay 6, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF AN 840 VENTILATOR WAS UNABLE TO HOLD CHARGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) EVALUATED THE DEVICE AND REPLACED THE BACK-UP POWER SUPPLY (BPS) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6550625 ↗
• MalfunctionMay 6, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A LOSS OF BREATH DELIVERY (BD) COMMUNICATION ERROR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE ISSUE REPORTED. NO PARTS WERE REPLACED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6550057 ↗
• MalfunctionMay 4, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC TOP DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE SOFTWARE TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6545817 ↗
• MalfunctionApr 5, 2017Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT THERE WAS AN OXYGEN SENSOR MALFUNCTION. THERE WAS NO PATIENT HARM REPORTED. THE SERVICE ENGINEER EVALUATED THE VENTILATOR AND REPLACED THE OXYGEN SENSOR. THE VENTILATOR PASSED SELF-TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6461172 ↗
• MalfunctionApr 4, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THE VENTILATOR GENERATED AN ERROR WHICH RENDERED THE VENTILATION INOPERABLE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6457252 ↗
• MalfunctionMar 30, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THIS MEDWATCH REPORT WAS INADVERTENTLY SUBMITTED. THE ISSUE REPORTED WAS ADDRESSED IN REGULATORY REPORT #8020893-2017-05484.

  Patient problems: No Information

  MAUDE report 6447070 ↗
• MalfunctionMar 30, 2017No Display/Image; Device Inoperable; No Display/Image; Device Inoperable

  IT WAS REPORTED THAT, AN 840 VENTILATOR FAILED THE POWER ON SELF-TEST (POST). THE VENTILATOR EXHIBITED A LOUD WHISTLE AND THE DISPLAY SCREEN WAS BLACK. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION. THE SE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE SOFTWARE TO THE LATEST REVISION. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6447042 ↗
• InjuryMar 29, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A SCREEN BLOCKED ERROR WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) TOUCH FRAME PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Code Available

  MAUDE report 6443166 ↗
• MalfunctionMar 24, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT, AN 840 VENTILATOR SHUT DOWN AFTER CYCLING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND BACKLIGHT INVERTER PCBS. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6432187 ↗