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

Model Number 99999

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

A spacelabs field service engineer performed an investigation of the service logs and confirmed the reported complaint.The field service engineer replaced the power supply, the power supply cable, and reloaded the software.Performance checks were completed and operational status verified.During the display of the failed state for this device, the patient can still be hand ventilated with anesthesia gases and oxygen, regulators still register and an alarm sounds continuously.These devices are constantly attended and the licensed clinicians in attendance have the means from the device to maintain patient safety.Consequently, there is not risk for serious patient harm and this is not a reportable event.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) 2017 that the arkon anesthesia machine ceased functioning and emitted a long beeping sound.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: 7567540
• MDR Text Key: 110466348
• Report Number: 9611295-2018-00029
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 99999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2015
• 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