MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS HEALTHCARE TELEMETRY RECEIVER; XTR

Model Number 96280

Device Problem Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

Spacelabs field service engineer investigation findings show that there was evidence of a loss of communication with the telemetry receiver.In all case a sudden power loss was found during investigation.The cause of this specific occurrence was determined, to be a faulty ups.As per spacelabs¿ engineer¿s recommendations, customer replaced the faulty ups.This investigation is considered complete and the issue closed.

Event Description

Spacelabs received a report on may 4th, 2020 that there was three instances of telemetry off-line.Telemetry were interrupted for 15 minute of monitoring with the enhanced telemetry receiver.

• Brand Name: SPACELABS HEALTHCARE TELEMETRY RECEIVER
• Type of Device: XTR
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: marc rivas ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635568
• MDR Report Key: 10116805
• MDR Text Key: 204695707
• Report Number: 3010157426-2020-00006
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K141156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/01/2005,06/03/2020

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: 96280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 06/03/2020
• 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