MAUDE Adverse Event Report: SPACELABS HEALTHCARE (WASHINGTON), INC; MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)

Model Number 90469

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2021

Event Type  malfunction  

Event Description

Unable to continuously monitor respirations due to malfunctioning spacelab cartridge.No patient harm.Biomed in house follow up - customer reported respirations not able to be monitored.After inspecting device and talking to tech support, we found the device was manufactured without the respiration option built in.All other functions were successfully tested.The charge nurse informed me that if the module could not take respirations they would not want to use it, so i have the device in the biomed shop.

• Type of Device: MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS)
• Manufacturer (Section D): SPACELABS HEALTHCARE (WASHINGTON), INC; 35301 se center st; snoqualmie WA 98065
• MDR Report Key: 11320950
• MDR Text Key: 231590130
• Report Number: 11320950
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2021

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: 90469
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1