MAUDE Adverse Event Report: SPACELABS HEALTHCARE LTD. SPACELABS ARKON ANESTHESIA WORKSTATION; ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR

Model Number 99999

Device Problems Self-Activation or Keying (1557); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

The spacelabs¿ field service engineer investigated the failed state.The device was rebooted, and passed all tests.During the described failed state, the arkon automatically activates the emergency oxygen and the licensed clinician, who is in constant attendance, can continue to manually ventilate the patient while power cycling the device which resolves the issue.The investigation findings showed no risk of serious harm to the patient and no serious risk should the event recur, however spacelabs is filing reports of similar issues as requested by the fda letter dated october 10, 2017.

Event Description

Spacelabs received a report on (b)(6) 2018 that the arkon anesthesia machine entered a failed state and experienced an unexpected display unit reboot while on a patient.No injury was reported with this event.

• Brand Name: SPACELABS ARKON ANESTHESIA WORKSTATION
• Type of Device: ANESTHESIA WORKSTATION WITH CONTINUOUS VENTILATOR
• Manufacturer (Section D): SPACELABS HEALTHCARE LTD.; unit b, foxholes centre; john tate road; hertford SG13 7NW; UK SG13 7NW
• Manufacturer Contact: michael frey ; 35301 se center st.; snoqualmie, WA 98065 ; 425 363-56
• MDR Report Key: 7602921
• MDR Text Key: 111894930
• Report Number: 9611295-2018-00033
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 99999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1