MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL COMMAND MODULE; ULTRAVIEW SL MULTIPARAMETER MODULE

Model Number 91496

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has attempted to collect historical waveforms and trend data from the ics database, but due to the amount of time from the date of occurrence to when the customer reported the issue, the data had already been purged.Onsite testing of the involved devices conducted by a spacelabs field service engineer confirmed that the equipment performed to specifications.The testing was witnessed by a facility staff member.Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report on august 31, 2016 between 2:13 am to 2:16am, a run of ventricular tachycardia (vtach) did not alarm for vrun at the bedside or central monitor.No one was injured as the result of this event.

Manufacturer Narrative

During investigation, the reported incident was clarified to involve a pause in the ecg waveform that did not alarm at the bedside and central monitor, as opposed to the initial report of vtach that did not alarm.The patient's waveform information was reviewed by a spacelabs lead software engineer.Findings show that the event did not meet the criteria for an asystole alarm and the device performed to specifications.This report is considered final and the issue is closed.

• Brand Name: SPACELABS ULTRAVIEW SL COMMAND MODULE
• Type of Device: ULTRAVIEW SL MULTIPARAMETER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: daniel herrera ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635631
• MDR Report Key: 5992221
• MDR Text Key: 56453206
• Report Number: 3010157426-2016-00140
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103142
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2017

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: 91496
• Other Device ID Number: 2.02.06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2009
• 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: (B)(4)
• Patient Age: 67 YR
• Patient Weight: 69