MAUDE Adverse Event Report: SPACELABS HEALTHCARE INC. ARIATELE TELEMETRY TRANSMITTER

Model Number 96281

Device Problem No Audible Alarm (1019)

Patient Problem Torsades-de-Pointes (2107)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Spacelabs field service engineer (fse) has examined the equipment, which is still in patient use.Fse has found no malfunction that would contribute to the issue that is being reported.The device continues to be used without further reported issued this report is complete and this particular issue is considered to be closed.

Event Description

Spacelabs received a report that a patient experienced an episode of torsades de pointes in which the audible alarm did not sound on the bedsided monitor or the central nursing unit.No injury was reported in association with this event.

• Brand Name: ARIATELE TELEMETRY TRANSMITTER
• Type of Device: ARIATELE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie 98065
• Manufacturer Contact: david geraghty ; 35301 se center st.; snoqualmie, WA 98065 ; 4253635889
• MDR Report Key: 9722437
• MDR Text Key: 198524144
• Report Number: 3010157426-2020-00002
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K121480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/01/2005,02/18/2020

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: 96281
• 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: 01/17/2020
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2019
• 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