Pneupac 520A1299USRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10610586045721), received between Aug 14, 2018 and Mar 27, 2024 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Failure to Cycle” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K051322); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GREEN MANUAL VENTILATION BUTTON WAS MISSING. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

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

  MAUDE report 18988381 ↗
• MalfunctionSep 15, 2023Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE DEVICE DOES NOT VENTILATE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17761110 ↗
• MalfunctionAug 9, 2023Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE DEVICE NEEDED REPAIR FOR NOT CYCLING. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17494434 ↗
• MalfunctionOct 13, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT DO THE BREATHS CORRECTLY ON THE ADULT SETTING - EVERY SIX SECONDS, THERE WAS A CONSTANT BLOW OF AIR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601104 ↗
• MalfunctionAug 24, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE MANUAL BUTTON WOULD NOT WORK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15285014 ↗
• MalfunctionJun 8, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE VENTILATOR WOULD NOT VENTILATE. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14635672 ↗
• MalfunctionMar 11, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE UNIT WILL NOT VENTILATE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13742001 ↗
• MalfunctionMar 2, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE SELECTOR LEVER IS STUCK. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13653249 ↗
• MalfunctionDec 16, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE VENTILATOR IS NOT VENTILATING AT THE PROPER RATE. WILL FREE FLOW AIR WITHOUT STOPPING.:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13021952 ↗
• MalfunctionNov 7, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE MANUAL/AUTO SWITCH DOES NOT STAY LOCKED WHEN IT'S BEING USED, ON A SMITHS MEDICAL VENTILATOR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12764020 ↗
• MalfunctionJul 8, 2021Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS/PNEUPAC VENTILATORS VR1 STANDARD IT WILL NOT CYCLE, AS IT HAS CONTESTANT PRESSURE IN ADULT MODE.

  Patient problems: Insufficient Information

  MAUDE report 12135509 ↗
• MalfunctionMay 7, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT SMITHS MEDICAL VENTILATOR HAD AUTO MANUAL CONTROL DID NOT WORK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 11794549 ↗
• MalfunctionFeb 5, 2021Leak/Splash; Device Fell; Leak/Splash; Device Fell

  IT WAS REPORTED THAT A CUSTOMER DROPPED A SMITHS MEDICAL VENTILATOR AND IT'S LEAKING INTERNALLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11290172 ↗
• MalfunctionSep 1, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  INFORMATION WAS RECEIVED INDICATING THAT THE AUTO AND MANUAL DIAL TO A SMITHS MEDICAL PNEUPAC VR1 BECAME STUCK. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Information

  MAUDE report 10479740 ↗
• MalfunctionJul 14, 2020Component Missing; Component Missing

  INFORMATION RECEIVED A SMITHS MEDICAL PNEUPAC VENTILATOR IS MISSING A GASKET THAT'S INSIDE. THIS WAS DISCOVERED PRIOR TO PATIENT USE AND NO PATIENT INJURY OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 10273100 ↗
• MalfunctionJul 1, 2020Break; Power Problem; Break; Power Problem

  INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS/PNEUPAC VENTILATORS VR1 STANDARD BREAKING PUSH BUTTON, NO PATIENT ADVERSE EVENT OR INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10220645 ↗
• MalfunctionMay 28, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THE UNIT WAS NOT FUNCTIONING PROPERLY. WHEN IN AUTO MODE, IT DID NOT STOP BLOWING AIR. WHEN IN MANUAL MODE, AND THE BUTTON WAS PRESSED, THE UNIT DID NOT STOP BLOWING WHEN THE TIDAL VOLUME WAS REACHED. THE DEVICE DID NOT PRODUCE ANY ALARMS. THE PRODUCT PROBLEM WAS OBSERVED ON (B)(6) 2019. THERE WAS NO PATIENT INVOLVEMENT. THE PROBLEM WAS OBSERVED DURING TESTING. THE CUSTOMER NOTED THAT THE VENTILATOR WAS NOT SERVICED SINCE IT WAS ORIGINALLY PURCHASED.

  Patient problems: No Patient Involvement

  MAUDE report 10098380 ↗
• MalfunctionApr 25, 2019Use of Incorrect Control/Treatment Settings; Defective Component; Use of Incorrect Control/Treatment Settings; Defective Component

  INFORMATION WAS RECEIVED THAT THE MODES FOR 'AUTO' AND 'MANUAL' ON A SMITHS MEDICAL PNEUPAC VR1 VENTILATOR "KEEP SLIPPING BACK TO MANUAL". NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8552893 ↗
• MalfunctionDec 19, 2018Tidal Volume Fluctuations; Tidal Volume Fluctuations

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PNEUPAC VR1 WAS NOT CYCLING. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8181870 ↗
• MalfunctionAug 14, 2018Tidal Volume Fluctuations; Tidal Volume Fluctuations

  IT WAS REPORTED THAT THE TIDAL VOLUME READING WAS HIGH ON THE PNEUPAC VENTILATOR. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051322. One submission often covers many models, so check the product and lot details in each record.

• Z-0991-2007 · May 16, 2007 · Terminated
  Pneupac VR1 Standard and VR1 Responder is a hand held portable, time cycled, gas powered, flow generator ventilatory resuscitators that are intended for emergency resuscitation by