MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. SPACELABS TELEMETRY RECIEVER HOUSING; TELEMETRY HOUSING

Model Number 90479

Device Problems Disconnection (1171); Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Spacelabs¿ field service engineer was notified of the customer¿s intermittent loss of telemetry monitoring in the hospital environment.An evaluation of the antenna telemetry system was performed with the customer¿s biomedical engineer.They were able to verify proper functionality of the system.Investigative findings are unable to determine the cause of this issue as the event occurs intermittently in the hospital environment.This report is complete and this particular issue is considered closed.

Event Description

Spacelabs received a report on (b)(6) 2018 that there was a loss of monitoring of 14 telemetry patients on the antenna telemetry system for 20 minutes.No injury was reported with this event.

• Brand Name: SPACELABS TELEMETRY RECIEVER HOUSING
• Type of Device: TELEMETRY HOUSING
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie WA 98065
• Manufacturer Contact: michael frey ; 35301 se center st.; snoqualmie, WA 98065 ; 425 363-56
• MDR Report Key: 7407328
• MDR Text Key: 105291595
• Report Number: 3010157426-2018-00063
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925510
• 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
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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