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

Model Number 90478

Device Problem Device Alarm System (1012)

Patient Problems Cardiac Arrest (1762); Fall (1848); Head Injury (1879)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

Onsite testing by a spacelabs field service engineer confirmed that the involved devices performed to specifications.The testing was witnessed by a hospital representative.The patient's historical waveforms and trend information was collected by the fse and sent to spacelabs for analysis.Spacelabs will file a supplemental report when the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2016 at approximately 5:41 am the central monitor did not alarm when a telemetry patient experienced an episode of asystole.The patient fell and hit her head during the episode (cat scan negative) and remains hospitalized with no further reported changes.

Manufacturer Narrative

The patient's historical waveforms and trend information were reviewed by a spacelabs software engineer.Findings show that the telemetry receiver module detected the episode and generated an asystole alarm.The device performed to specifications.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: daniel herrera ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635631
• MDR Report Key: 6112918
• MDR Text Key: 60353345
• Report Number: 3010157426-2016-00183
• 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: Nurse
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• 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: 05/31/2011
• 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): Other
• Patient Age: 21 YR
• Patient Weight: 71