DeltaXL Monitor MS18596Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04049098004169), received between Feb 16, 2024 and Aug 29, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT THE DELTA XL WENT BLACK BUT THAT BEEPING COULD STILL BE HEARD. SHE SAID AFTER THEIR CHECK IN THE MORNING THEY HOOKED UP ALL THE LEADS AND PUT IT IN STANDBY. NO ADVERSE PATIENT IMPACT OR DEATH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20098712 ↗
• InjuryMay 28, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT, WHILE PREPARING FOR SURGERY, THE SP02 VALUE COULD NOT BE VIEWED ON THE MONITOR, AND THAT USERS SWAPPED OUT THE DEVICE. THE PATIENT HAD BEEN HOSPITALIZED FOR ACUTE APPENDICITIS ON (B)(6) 2023, DUE TO UNDERGO A LAPAROSCOPIC APPENDECTOMY THE SAME DAY. THE PATIENT WAS BEING ADMINISTERED A SODIUM CHLORIDE INJECTION AS PART OF THE PROCEDURE. ECG MONITORING WAS REPORTED TO FUNCTION, BUT NO BLOOD OXYGEN SATURATION WAS DISPLAYED, AND THE USERS SWAPPED OUT THE MONITORING DEVICE, REPORTING A PROLONGING OF ADMINISTRATION OF ANESTHESIA. NO PATIENT INJURY OR DEATH WAS REPORTED.

  Patient problems: Inflammation

  MAUDE report 19404063 ↗
• MalfunctionApr 22, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT THE PATIENTS CARBON DIOXIDE VALUES AND WAVEFORMS COULD NOT BE DISPLAYED ON THE DELTA DURING OPERATION, AND THAT THE ANESTHESIOLOGIST COULD NOT JUDGE THE PATIENT'S CONDITION. THERE WAS NO REPORT OF PATIENT INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153114 ↗
• MalfunctionApr 5, 2024Insufficient Device Problem Information; Unexpected Shutdown; Insufficient Device Problem Information; Unexpected Shutdown

  THE CUSTOMER REPORTED THAT THE DELTA XL DISPLAY LAGGED WHEN THE ROTARY KNOB WAS USED, AND THAT THE PATIENT VITAL DISPLAY WAS INTERRUPTED AND RESET. ONCE THE ENDOSCOPY CASE WAS FINISHED, THE DELTA XL RESTARTED WITHOUT ALARMS. THE ANESTHESIA MACHINE IN USE WAS NOT IMPACTED, AND THERE WAS NO REPORTED INJURY OR PATIENT DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051509 ↗
• MalfunctionFeb 16, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE USER WITNESSED A PATIENT WITH A HIGH HEART RATE, BUT THE PATIENT MONITOR DID NOT APPEAR TO BE VISUALLY SHOWING THE PATIENTS SYMPTOMS. THERE WAS NO REPORT OF AN ADVERSE EVENT OR PATIENT INJURY.

  Patient problems: Tachycardia

  MAUDE report 18720781 ↗

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-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-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-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-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-0582-2010 · Nov 9, 2009 · Terminated
  Delta/Delta XL Monitors with Omega S Package