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

Model Number 99999

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

A spacelabs field service engineer performed an investigation of the device and confirmed the reported failed state, however the display color issue could not be reproduced by the fse.The system¿s power was cycled and normal operation resumed, the device passed all tests and was returned to service.During the reported 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 that on (b)(6) 2017, the arkon experienced a failed state and the display colors changed and reset during use.No injury was reported as a result of 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: 7045761
• MDR Text Key: 93423487
• Report Number: 9611295-2017-00085
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/20/2017

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: 99999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2015
• 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