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

Model Number 91496

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Tachycardia (2132)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

The customer¿s biomed tested the module and could not reproduce the symptom.The biomed is sending the module to spacelabs for additional testing.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.Spacelabs has launched an investigation and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2016 at approximately 4:00 am, a run of ventricular tachycardia (vtach) did not alarm for vrun at bedside or central monitor.No one was injured as a result of this event.

Manufacturer Narrative

The customer biomed tested the involved devices and could not reproduce the symptom.A spacelabs field service engineer went on-site and confirmed that all tests passed.The customer opted to send the nine year old device to spacelabs depot repair for further evaluation.The patient's historical waveforms and trend information were no longer available because the data had been purged.Spacelabs service center received the device and the cpu board was replaced, however no correlation could be made between the replaced part and the reported event.The repaired unit passed all functional tests and was restored to service.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: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 5918253
• MDR Text Key: 54295909
• Report Number: 3010157426-2016-00086
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

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: 2.04.03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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