MAUDE Adverse Event Report: SPACELABS HEALTHCARE SPACELABS HEALTHCARE; CAPNOGRAPHY MODULE

Model Number 92516

Device Problems Defective Alarm (1014); Loss of Power (1475); Self-Activation or Keying (1557)

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

Event Date 04/07/2017

Event Type  malfunction  

Event Description

Failure identified by biomedical engineering with spacelabs respiratory monitoring module.If the occlusion alarm is triggered (occlusion of the end-tidal co2 monitoring device) the alarm will sound 3 times within 60 seconds.If the occlusion is not addressed within that 60 second period, the system turns off the respiratory monitoring completely with a message saying such, but no further audio or visual alarm will sound just shuts down that monitoring module (cardiac monitor will continue uninterrupted, but losing the respiratory monitoring).Spacelabs has been informed- exact problem not yet identified within the system- spacelabs was assisting biomedical engineering.

• Brand Name: SPACELABS HEALTHCARE
• Type of Device: CAPNOGRAPHY MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE; issaquah WA
• MDR Report Key: 6507471
• MDR Text Key: 73377079
• Report Number: MW5069210
• Device Sequence Number: 1
• Product Code: CCK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 92516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1