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

Model Number 99999

Device Problems Nonstandard Device (1420); Fail-Safe Problem (2936)

Patient Problem No Patient Involvement (2645)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

A spacelabs field service engineer performed an investigation of the device including the logs and confirmed the reported complaint.Power cycling the device resolves the issue.The hospital biomed performed a full checkout of the device and the device passed all tests.The investigation findings showed no risk of serious harm 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 went into a "safe failed state" in an unattended theater.No patient was attached, 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 SG137 DT; UK SG137DT
• Manufacturer Contact: david geraghty ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635889
• MDR Report Key: 8103794
• MDR Text Key: 129353214
• Report Number: 9611295-2018-00047
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K113051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/01/2005,10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2589-2018
• Patient Sequence Number: 1