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

Model Number 90478

Device Problem Telemetry Discrepancy (1629)

Patient Problem Bradycardia (1751)

Event Date 03/04/2017

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation into this event and will file a supplemental report once the investigation is complete.

Event Description

Spacelabs received a report that on (b)(6) 2017, a telemetry bed did not display an accurate heart rate at the central monitor when a patient experienced an episode of irregular bradycardia following a pause.No one was injured as a result of this event.

Manufacturer Narrative

The patent's historical data was collected and sent to spacelabs for further analysis by a lead software engineer.Findings show that the heart rate that the user viewed on the strip is collected from the monitor¿s tabular trend data and time stamped with the captured heart rate from the previous minute, as designed.The device performed to specifications and education was provided to the customer.This investigation is considered complete and the matter 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: carolyn hosea ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635924
• MDR Report Key: 6455139
• MDR Text Key: 71839191
• Report Number: 3010157426-2017-00030
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

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: 90478
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• 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