MAUDE Adverse Event Report: SPACELABS HEALTHCARE TELEMETRY RECEIVER HOUSING

Model Number 90479

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Manufacturer Narrative

A spacelabs field service engineer (fse) was dispatched to investigate the reported issue.During their investigation, the fse found that the customer had their uvsl receiver housing connected to a faulty uninterruptable power supplies (ups).The customer, a biomedical engineer, was made aware of the findings and confirmed that they will replace faulty ups. the cause of the reported issue was due to the customer's faulty ups.

Event Description

The customer reported that following a power disruption at their facility, several uvsl telemetry receivers had not recovered.There was no patient or user death, or injury associated with the event.

• Brand Name: TELEMETRY RECEIVER HOUSING
• Type of Device: TELEMETRY RECEIVER HOUSING
• Manufacturer (Section D): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA 98065
• Manufacturer (Section G): SPACELABS HEALTHCARE; 35301 se center st; snoqualmie WA
• Manufacturer Contact: whitney snyder ; 35301 se center st; snoqualmie, WA 98065
• MDR Report Key: 16584466
• MDR Text Key: 312200653
• Report Number: 3010157426-2023-00025
• 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,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2023
• 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