MAUDE Adverse Event Report: MINDRAY DS USA, INC. MINDRAY A7 ANESTHESIA MACHINE; GAS-MACHINE, ANESTHESIA

Model Number A7

Device Problems Free or Unrestricted Flow (2945); Mechanics Altered (2984); Physical Resistance/Sticking (4012)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Overinflation of Lung (2397)

Event Date 06/15/2022

Event Type  Injury  

Event Description

Summary: mindray a7 anesthesia machine had a stuck expiratory valve which caused severe lung hyperinflation, bradycardia, and hypotension, nearly resulting in patient death.I am the attending anesthesiologist who was present for the entire event detailed below.59 yr old man with pmh (past medical history) of htn (hypertension), ckd (chronic kidney disease), hld (hyperlipidemia), who presented to er with headaches, found to have subdural hemorrhage.He was admitted for urgent craniotomy.We ran a routine anesthesia machine check prior to starting the case, which the machine passed.After induction of anesthesia and intubation, the anesthesia team noted progressively increasing airway pressures, poor lung compliance, and a sawtooth end-tidal co2(carbon dioxide) pattern of the capnography.The patient's chest became progressively hyperinflated.He became unstable, with marked hypotension and bradycardia.We trouble-shooted the issue to rule out mucus plugging, mainstem bronchial intubation, bronchospasm, pneumothorax, and machine malfunction.While doing maneuvers to distinguish which issue was present, we simultaneously resuscitated him with epinephrine.Now highly suspicious of possible anesthesia machine dysfunction, we switched to an ambu self-inflating bag, which immediately resolved the hemodynamic and ventilation issues.We then identified a stuck expiratory valve on the machine, which we unstuck and cleaned.This was clearly the root cause of the issue, which nearly resulted in the patient's death.We then ran a diagnostic machine check, which the machine passed.We continued the urgent case with the same machine without further event.After the case, we took the machine out of service until further diagnostics could be performed.I submitted an unusual event report to our (b)(6) reporting system.I notified the anesthesiology department leadership.I notified mindray.The machine at the time of the event had repeated high pressure alarms, which mindray noted in their follow-up with me.They did not find an issue with the valve, to which i responded that's because i'd already un-stuck and cleaned the valve.Fda safety report id# (b)(4).

• Brand Name: MINDRAY A7 ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MINDRAY DS USA, INC.
• MDR Report Key: 15673751
• MDR Text Key: 302515218
• Report Number: MW5112854
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American