Puritan Bennett 4-840220DIEC-SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884521077058), received between Mar 29, 2017 and Dec 6, 2022 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (4 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2022Smoking; Smoking

  IT WAS REPORTED THAT THIS 840 VENTILATOR EMITTED SMOKE FROM THE EXPIRATORY BLOCK.  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15924166 ↗
• MalfunctionNov 24, 2021No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT, WHEN THE 840 VENTILATOR WAS TURNED ON, THE UNIT GENERATED A BEEPING SOUND AND THE SCREEN WOULD NOT TURN ON. IT WAS ALSO REPORTED THAT UNIT WOULD NOT STOP BEEPING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. REPORTABILITY REASSESSED BASE ON THE PRODUCT ANALYSIS FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12871058 ↗
• MalfunctionFeb 11, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING SERVICE THE 840 VENTILATOR GENERATED A BACKGROUND FAULT ERROR CODE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8327859 ↗
• MalfunctionFeb 8, 2019No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR ALARMED LOSS OF COMMUNICATION AND THE SCREEN WOULD NOT TURN ON; THE UNIT WAS REPORTED TO HAVE GENERATED AN INOPERABLE ERROR CODE. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 8323882 ↗
• MalfunctionJun 6, 2018Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  IT WAS REPORTED THAT THE 840 VENTILATOR FAILED THE SHORT SELF TEST (SST). THE VENTILATOR EXPERIENCED SMOKE 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 7575356 ↗
• MalfunctionNov 3, 2017Device Inoperable; Inappropriate or Unexpected Reset; Device Inoperable; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE 840 VENTILATOR HAD SHUT DOWN WITHOUT ANY ALARM. 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.

  Patient problems: No Code Available

  MAUDE report 7000720 ↗
• MalfunctionAug 24, 2017No Display/Image; No Display/Image

  IT WAS REPORTED AN 840 VENTILATOR HAD A FROZEN/LOCKED SCREEN. ALTHOUGH REQUESTED IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER REPLACED THE TOUCH FRAME/DISPLAY. THE SERVICE ENGINEER PERFORMED TESTING AND CALIBRATIONS AND THE UNIT OPERATED WITHIN THE MANUFACTURER'S SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6818126 ↗
• MalfunctionAug 21, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE, THE 840 VENTILATOR DID NOT PASS THE EXTENDED SELF-TEST (EST), THE LOWER DISPLAY DID NOT VIEW PROPERLY AND THE KEYBOARD DID NOT WORK PROPERLY (BLOCKED ERROR MESSAGE).

  Patient problems: No Patient Involvement

  MAUDE report 6808558 ↗
• MalfunctionAug 15, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR GENERATED A SAFETY VALVE OUT OF RANGE ERROR MESSAGE WHICH RENDERED THE DEVICE INOPERABLE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. A SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6794985 ↗
• MalfunctionAug 8, 2017Device Inoperable; Device Inoperable

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

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6775593 ↗
• MalfunctionAug 4, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A SCREEN LOCK ERROR. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6768920 ↗
• MalfunctionAug 1, 2017No Audible Alarm; No Flow; No Audible Alarm; No Flow

  IT WAS REPORTED THAT THE 840 VENTILATOR HAD A VENT INOP ALARM FAILURE. INFORMATION ABOUT PATIENT INVOLVEMENT WAS NOT PROVIDED. THE SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB) THE ANALOG INTERFACE (AI) PCB AND THE EXHALATION VALVE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6758201 ↗
• MalfunctionJul 31, 2017Battery Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED, THE CUSTOMER STATED THAT A NON-MEDTRONIC BATTERY WAS USED AT THE TIME OF THE REPORTED EVENT. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6755589 ↗
• MalfunctionJul 31, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A SCREEN BLOCKED DUE TO BEING DROPPED AND DAMAGED. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE GUI CPU (GRAPHICAL USER INTERFACE CENTRAL PROCESS UNIT) AND BACKLIGHT INVERTER TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6753946 ↗
• MalfunctionJul 28, 2017Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, WHEN AN 840 VENTILATOR WAS TURNED THE DEVICE FAILED THE POST (POWER ON SELF-TEST). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND BACKLIGHT INVERTER PCBS. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6752586 ↗
• MalfunctionJul 28, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, AN 840 VENTILATOR GENERATED AN OXYGEN (O2) SENSOR ERROR MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED CONDITION. THE SE CALIBRATED THE O2 SENSOR AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

  Patient problems: No Patient Involvement

  MAUDE report 6752555 ↗
• MalfunctionJul 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD AN OXYGEN SENSOR MALFUNCTION DURING SST. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED AND VERIFIED THE ISSUE REPORTED. THE SE FOUND A LEAK IN THE EXHALATION VALVE. THE SE REPAIRED THE LEAK BY RE-INSTALLING THE EXHALATION VALVE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURES SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6747631 ↗
• MalfunctionJul 17, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A FAULTY DISPLAY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), UPGRADED THE BACKLIGHT INVERTER PCBS AND DOWNLOADED THE RECENT VERSION OF THE SOFTWARE. THE VENTILATOR PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER'S SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6719422 ↗
• MalfunctionJul 11, 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 ISSUE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6702876 ↗
• MalfunctionJun 14, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR WAS BLOCKED AND COULD NOT VENTILATE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 6641392 ↗
• MalfunctionJun 13, 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 SERVICE ENGINEER REPLACED THE GUI CPU (GRAPHICAL USER INTERFACE) BOARD, BACKLIGHT INVERTER AND UPLOADED SOFTWARE TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6638273 ↗
• MalfunctionJun 5, 2017Communication or Transmission Problem; Communication or Transmission Problem

  A GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND BACKLIGHT INVERTERS PCB WERE 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 RE PORTED ISSUE ON THE GUI PCB WAS ISOLATED TO A COMPONENT (COAXIAL TRANSCEIVER INTERFACE U35). NO FAILURE WAS FOUND ON THE BACKLIGHT INVERTERS PCB.

  Patient problems: No Patient Involvement

  MAUDE report 6613367 ↗
• MalfunctionJun 1, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A BLANK DISPLAY WHEN DEVICE WAS TURNED ON. 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), THE BACKLIGHT INVERTER PCB¿S WERE UPDATED AND INSTALLED THE LATEST VERSION OF THE OPERATIONAL SOFTWARE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6604222 ↗
• MalfunctionMay 22, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A LOSS OF COMMUNICATION BETWEEN THE GRAPHIC USER INTERFACE (GUI) DISPLAY AND THE BREATH DELIVERY UNIT (BDU). 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 BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB), THE GRAPHICAL USER INTERFACE (GUI) PCB, THE BACKLIGHT INVERTER PCBS, AND SOFTWARE WAS UPDATED TO THE CURRENT REVISION. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6583539 ↗
• MalfunctionMay 15, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD AN ERRATIC (RED) DISPLAY. 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 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 6568061 ↗