inforMED
MalfunctionBZG

SPIROBANK II

Received Feb 14, 2025 · Event occurred Jan 24, 2025

Report 21383968 · MDR key 21383968

Device

Generic name

Spirometer, Diagnostic

Patient

58 YR · Female

  • Respiratory Failure
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Respiratory Failure
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

PATIENT WITH MUSK (MUSCLE-SPECIFIC KINASE) ANTIBODY POSITIVE MYASTHENIA GRAVIS ADMITTED FOR MYASTHENIA GRAVIS EXACERBATION WITH RESPIRATORY FAILURE. AFTER 2 ATTEMPTS OF OBTAINING PARAMETERS FROM PATIENT, THIS THERAPIST RECOGNIZED THE VALUES WERE UNCHANGING. A SECOND FILTER WAS PLACED, AND THIS THERAPIST ATTEMPTED MANEUVERS AGAIN AND THE SAME RESULTS WERE DISPLAYED ON DEVICE. A SECOND DEVICE WAS USED TO OBTAIN PARAMETERS WHICH WERE REPEATABLE AND SIGNIFICANTLY LESS. DOCUMENTATION: "QUESTIONABLE RESULTS OF PREVIOUS VC (VITAL CAPACITY) OF 2.1L. SPIROMETER NOTED TO BE REGISTERING REPETITIVE RESULTS THAT WERE POSSIBLY INACCURATE. SECOND DEVICE OBTAINED AND MEASURED VC OF 950ML AND 920ML. RESIDENT NOTIFIED OF DISCREPANCY AND DROP IN DOCUMENTED VALUES. NIF (NEGATIVE INSPIRATORY FORCE) REMAINS STABLE AT >-40CMH20."