MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECEIVER MODULE

Model Number 90478

Device Problem Defective Alarm (1014)

Patient Problem Ventricular Tachycardia (2132)

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2017 a telemetry patient experienced an episode of ventricular tachycardia (vtach) that did not alarm at the central monitor.No one was injured as a result of this event.

Manufacturer Narrative

A spacelabs field service engineer arrived onsite for further investigation.Findings show that the transmitter that was in use during the episode in question was unable to be located by the customer for testing.The remaining devices were tested by the fse and confirmed to perform to specification.The patient's historical waveforms and trend information were reviewed by a spacelabs lead software engineer.Findings show an episode of ventricular tachycardia (vtach) for the specified time period and that a corresponding vrun alarm generated.As the complaint episode had been appropriately classified and documented in the historical database and central monitor alarm indicators operated according to specifications when tested by a spacelabs field service engineer, we know of no reason that audible and visual alarm indicators would not have been present at the central monitor at the time of this complaint episode.This report is considered final and the issue closed.

• Brand Name: SPACELABS TELEMETRY RECEIVER MODULE
• Type of Device: TELEMETRY RECEIVER MODULE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: michael frey ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635622
• MDR Report Key: 6871263
• MDR Text Key: 86633719
• Report Number: 3010157426-2017-00079
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• 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