MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS ULTRAVIEW SL CENTRAL MONITOR; UVSL CENTRAL MONITOR

Model Number 91387-38

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 03/23/2015

Event Type  Death  

Event Description

Spacelabs received a report that a patient experienced ventricular fibrillation (vfib) and passed away on (b)(6) 2015 while monitored with central monitor model 91387-38.The central monitor did alarm for vfib; however, the nurse did not respond.The facility biomed discovered the tone configuration on the central monitor was set for a five second delay (the factory default value is zero seconds).

Manufacturer Narrative

On site testing conducted by a spacelabs field service engineer (fse) confirmed the involved equipment performed to specifications.Spacelabs has launched an investigation into this event and will file a supplemental report when the investigation is complete.Placeholder.

Manufacturer Narrative

When asked the facility declined to provide spacelabs the patient retrospective database, access the hospital server, a copy of encrypted device data, or a copy of any printed documentation of the event episode for analysis.Therefore, our investigation focused on verifying the performance of the bedside and central monitors.While on site the spacelabs field service engineer confirmed that there had been a high priority alarm notification for the reported event at both monitors.Additionally, at the time of the event the facility biomed confirmed that the central monitor configuration setting for high priority alarm tone was set for five seconds intervals instead of the default value of zero for a continuous alarm tone.There was no malfunction.The involved devices performed to specifications and user selected settings.This supplemental report is considered final and the issue closed.

• Brand Name: SPACELABS ULTRAVIEW SL CENTRAL MONITOR
• Type of Device: UVSL CENTRAL 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: 4712651
• MDR Text Key: 19637616
• Report Number: 3010157426-2015-00043
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91387-38
• Other Device ID Number: 2.03.07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• 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
• Patient Outcome(s): Death