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

Model Number 96281

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Spacelabs has launched an investigation and will file a supplemental report when the analysis is complete.

Event Description

Spacelabs received a report that on (b)(6) 2021, a battery overheated and burned the nurse.

Manufacturer Narrative

No fault found.Investigation showed hospital did not use the device on a patient.The field service engineer clarified that the rn was not burned but the batteries were warm to the touch.The hospital sent in the device for service repair to the battery compartment.This investigation is considered complete.

• Brand Name: ARIATELE TELEMETRY TRANSMITTER
• Type of Device: ARIATELE
• Manufacturer (Section D): SPACELABS HEALTHCARE INC.; 35301 se center st.; snoqualmie 98065
• MDR Report Key: 12456821
• MDR Text Key: 276675043
• Report Number: 3010157426-2021-00055
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): Y
• PMA/PMN Number: K121480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/17/2021

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
• 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: 08/23/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1