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

Model Number 90478

Device Problem Device Alarm System (1012)

Patient Problem Ventricular Tachycardia (2132)

Event Date 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

Onsite testing of the involved devices conducted by a spacelabs field service engineer confirmed a visual and audible alarm occurred with a simulated 11 beat run and a 5 beat run threshold.The equipment performed to specifications.The testing was witnessed by a hospital representative.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 2:59 p.M.A 28 beat run of ventricular tachycardia (vtach) did not alarm for vrun at the telemetry central station.No one was injured as a result of this event.

Manufacturer Narrative

The printout of the rhythm strip that was recorded during the event was reviewed by a spacelabs lead software engineer and verified that it satisfied the requirements for a run alarm.Based on the customer¿s statement that there was an alarm recording of the run alarm stored in the ics database and visible in clinical access, the monitor detected the episode, classified it as a run and generated an alarm.On site testing confirmed both visual and audible alarms, and that the device performs to specifications.There is no evidence of device malfunction.This report is considered final and the issue is 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: john zeng ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635915
• MDR Report Key: 5902637
• MDR Text Key: 53974152
• Report Number: 3010157426-2016-00078
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2016

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: 90478
• Other Device ID Number: 3.05.07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/23/2016
• 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 Age: 63 YR
• Patient Weight: 110