MAUDE Adverse Event Report: SPACELABS HEALTHCARE LTD. BLEASESIRIUS ANAESTHESIA SYSTEM; ANAESTHESIA GAS-MACHINE

Model Number 14200100

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 12/19/2013

Event Type  malfunction  

Event Description

Spacelabs received a report from a customer unable to ventilate a patient with the bleasesirius anesthetic machine.The machine passed full checkout prior to the case.After intubating the patient, the clinician was unable to ventilate the patient in bag mode.Clinician removed and replaced the valve dome cover.The machine was then used to complete the case without further incident.No patient injury was reported.

Manufacturer Narrative

A spacelabs field service engineer was sent onsite and tested the suspect device per the test procedure in the bleasesirius anesthetic machine technical manual 073-0227-00.The device passed all tests and is currently in use.Spacelabs is evaluating this occurrence and will file a supplemental report once our evaluation is concluded.Placeholder.

Manufacturer Narrative

The inspiratory and expiratory valves were removed and inspected by the clinician during the case with no significant moisture found.The machine remained in service at the customer site.Onsite testing of the involved device on (b)(6) 2013 by a spacelabs field service engineer (fse) confirmed that the equipment worked to specifications ¿ no defect was found and the machine passed all tests.Testing was performed after the clinician removed and replaced the dome covers.Tests included visual inspection of the parts and standard performance checks per the standard bleasesirius service checkout process.The testing was witnessed by a facility staff member.Spacelabs is continuing to trend complaints for this issue.This supplemental report is considered final and the customer issue is closed.

Event Description

Spacelabs received a report from a customer unable to ventilate a patient with the bleasesirius anesthesia machine (model 14200100) on december 19, 2013.The machine passed full checkout prior to the case.After intubating the patient, the clinician was unable to ventilate the patient in bag mode.The clinician removed and replaced the valve dome covers and the machine was then used to complete the case without further incident.No patient injury was reported.

• Brand Name: BLEASESIRIUS ANAESTHESIA SYSTEM
• Type of Device: ANAESTHESIA GAS-MACHINE
• Manufacturer (Section D): SPACELABS HEALTHCARE LTD.; 1 harforde court; john tate road; hertford SG13 7NW; UK SG13 7NW
• Manufacturer (Section G): SPACELABS HEALTHCARE LTD; 1 harforde court; john tate road; hertford SG13 7NW; UK SG13 7NW
• Manufacturer Contact: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 3583209
• MDR Text Key: 15203982
• Report Number: 9611295-2014-00002
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2012
• Device Model Number: 14200100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2011
• 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
• Treatment: ABSORBER MODEL #12200902 (ABSO-003900)
• Patient Outcome(s): Required Intervention