MAUDE Adverse Event Report: EATON CORP./EATON INTELLIGENT POWER LIMITED/EATON HOUSE SURGE PROTECTOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 93PM-150-3

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

Surge protector failed to prevent ge lab prucka from losing power and shutting down in the middle of an ablation while multiple catheters were in the body.Ups (uninterruptible power supply) had to be reset to regain power causing a greater than 15 minute delay in patient care.Reference reports: mw5117246.

• Brand Name: SURGE PROTECTOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EATON CORP./EATON INTELLIGENT POWER LIMITED/EATON HOUSE; 30 pembroke road.; dublin 4 D04 Y 0C2; EI D04 Y0C2
• MDR Report Key: 16876398
• MDR Text Key: 314715416
• Report Number: MW5117245
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 93PM-150-3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "MULTIPLE CATHETERS".
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White