MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS QUBE COMPACT MONITOR

Model Number 91390

Device Problems Device Alarm System (1012); Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/20/2014

Event Type  malfunction  

Event Description

Spacelabs received a report that a patient's spo2 saturation level went down to 87% and the qube patient monitor, model 91390, did not alarm.The customer also reported that spo2 alarm default setting is not holding.Each time new patient is admitted, spo2 alarm limits are off.Nurses need to manually enable alarm limits.

Manufacturer Narrative

Spacelabs field service engineer (fse) will be on-site for testing today.We will follow up with the fse for more information.No one has been injured as a result of this alleged malfunction.We will file a supplemental report when our investigation is concluded.

Manufacturer Narrative

It was reported that the spo2 alarm limits were off each time when a new patient was admitted even though the spo2 alarm limits default settings was turned on in the product module configuration manager (mcm).The nurse had to manually turn on the alarm limits.Spacelabs sent a field service engineer (fse) to evaluate the device onsite and obtain additional information from the clinical staff.Functional tests were performed on the monitor and module in accordance with the service manual.All tests passed.Our investigation found that the product performed as designed.When a new patient was admitted onto the monitor and the spo2 cable was connected to the module, but before the spo2 cable/sensor was connected to the patient¿s finger, the spo2 channel signed on with question mark ¿???¿ and spo2 alarm limits off.After the spo2 cable/sensor is connected to a patient¿s finger for 15 seconds, the spo2 waveform will display and spo2 alarm limits will automatically turn on.There is no need to manually turn these functions on.The operators manual states in clinical parameters (070-2113-02 page 9-31) that when the module is in the initialization phase (the first 15 seconds after sensor application) the spo2 value displays as question mark ¿???¿.Spacelabs¿ field service engineer explained the product operation to the customer.This report is considered final and the matter is closed.

Event Description

Spacelabs received a report that the bedside monitor, model 91390, failed to hold the spo2 alarm limits default settings.No one was injured as a result of this alleged malfunction.

• Brand Name: SPACELABS QUBE COMPACT MONITOR
• Type of Device: COMPACT MONITOR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 3958890
• MDR Text Key: 18039884
• Report Number: 3010157426-2014-00009
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2015

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: 91390
• Other Device ID Number: 3.03.00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 91496 V2.02.02; 91496 (B)(4) 2.02.02
• Patient Age: 65 YR