Infinity Vista XL Monitor MS18986Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049098003858), received between Jan 12, 2022 and Aug 1, 2024 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K070566); 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2024Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT ON (B)(6) 2024, AFTER THE PATIENT'S SURGERY AND EXTUBATION, THE OXYGEN SATURATION READING SHOWED SIGNIFICANT INTERFERENCE AND THE DEVICE REPORTEDLY DID NOT TRIGGER ANY ALARMS. THE DOCTOR NOTICED CYANOSIS AROUND THE PATIENT¿S MOUTH AND LIPS, INTERVENED PROMPTLY BY PROVIDING ASSISTED BREATHING TREATMENT, AND THE PATIENT'S CONDITION IMPROVED IMMEDIATELY. THE ISSUE WAS IDENTIFIED IN TIME AND DID NOT RESULT IN SIGNIFICANT HARM TO THE PATIENT. IT WAS REPORTED THAT THE SPRING OF THE PULSE OXIMETER HAD MALFUNCTIONED.

  Patient problems: Cyanosis

  MAUDE report 19883125 ↗
• MalfunctionAug 30, 2023Crack; Incorrect, Inadequate or Imprecise Result or Readings; Device Fell; Crack; Incorrect, Inadequate or Imprecise Result or Readings; Device Fell

  IT WAS REPORTED THAT TWO PATIENT MONITORING SYSTEMS THAT WERE MOUNTED TO THE WALL WITH A DEDICATED HOLDER FELL DOWN TO THE FLOOR. THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT A PATIENT, USER OR THIRD PERSON MAY HAVE BEEN HURT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Oxygen Saturation

  MAUDE report 17649557 ↗
• DeathSep 12, 2022No Audible Prompt/Feedback; No Audible Prompt/Feedback

  ON 5 SEP 2022 A COMPLAINT WAS RECEIVED REGARDING AN EVENT WHERE THE INVOLVED PATIENT DIED. THERE WAS AN ALLEGED REPORT OF A MALFUNCTION INITIALLY, BUT IT WAS VERIFIED THAT ALARMS WERE MANUALLY TURNED OFF FOR THE EVENT. ON 9 SEP 2022 NEW INFORMATION WAS RECEIVED STATING THAT THE CUSTOMER WAS ALLEGING THAT THE DEVICE NOT TRIGGERING AN ALARM DURING THE EVENT PLAYED A PART IN THE PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 15405519 ↗
• MalfunctionJan 12, 2022Fire; Fire

  IT WAS REPORTED THAT A FIRE INCIDENT OCCURRED WITH A DRAEGER VISTA XL MONITOR BEING USED WITH A COUNTERFEIT DRAEGER BATTERY (WITH DRÄGER LOGO STAMPED ON THE LABEL) THAT WAS INSTALLED BY A NON AUTHORIZED 3RD PARTY. NO ADVERSE PATIENT IMPACT WAS REPORTED. NOTE THAT THE FOLLOWING IS PROVIDED IN THE VISTA XL INSTRUCTIONS FOR USE: WARNING ONLY THE ITEMS INDICATED ON THE LIST OF ACCESSORIES IN THE ¿ACCESSORIES¿ CHAPTER HAVE BEEN TESTED AND APPROVED TO BE USED WITH THE DEVICE. ACCORDINGLY IT IS STRONGLY RECOMMENDED THAT ONLY THESE ACCESSORIES BE USED IN CONJUNCTION WITH THE SPECIFIC DEVICE. OTHERWISE THE CORRECT FUNCTIONING OF THE DEVICE MAY BE COMPROMISED. CAUTION: IT IS STRONGLY RECOMMENDED THAT YOU USE BATTERIES THAT ARE PROVIDED BY DRÄGER MEDICAL. THE USE OF NON-APPROVED BATTERIES MAY DAMAGE THE DEVICE. NOTE: CABLES AND ACCESSORIES NOT SPECIFIED WITHIN THE INSTRUCTIONS FOR USE ARE NOT AUTHORIZED. USING OTHER CABLES AND/OR ACCESSORIES MAY ADVERSELY IMPACT SAFETY, PERFORMANCE AND ELECTROMAGNETIC COMPATIBILITY (INCREASED EMISSION AND DECREASED IMMUNITY). UNDER APPROVED ACCESSORIES: EXTERNAL BATTERY PACK (SEALED LEAD ACID) 5592097.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238574 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070566. One submission often covers many models, so check the product and lot details in each record.

• Z-0281-2012 · Oct 31, 2011 · Terminated
  Draeger Infinity(R) Delta, Delta XL, Gamma XXL and Kappa Monitors are used to monitor, physiologically, the vital signs of patients (with Arrhythmia Detection or Alarms).
• Z-3047-2011 · Jul 29, 2011 · Terminated
  Infinity Delta Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and tr
• Z-3048-2011 · Jul 29, 2011 · Terminated
  Infinity Gamma X XL Portable Patient Monitor. Draeger Medical Systems, Inc. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside a
• Z-2283-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-2284-2010 · Jun 4, 2010 · Terminated
  Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications.
• Z-0582-2010 · Nov 9, 2009 · Terminated
  Delta/Delta XL Monitors with Omega S Package