MAUDE Adverse Event Report: EATON CORPORATION TRIPPLITE POWER OUTLET, POWER TAP; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number PS-415-HG-OEM UL 1363A

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585); Use of Device Problem (1670); Electrical Overstress (2924)

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

Event Date 03/20/2023

Event Type  Other  

Event Description

During the end of a procedure, an operating room staff member smelled a smoke-like odor that was identified as overheating of the outlets on a relocatable power tap (rpt) located next to the operating room table.Patient was unaffected; no flame or fire.The rpt(radiopharmaceutical therapy) was mounted on an equipment assembly next to the operating room table.Upon smelling, then seeing smoke coming from the outlets, the assembly was moved away from the table, all devices were unplugged, and the rpt(radiopharmaceutical therapy) was unplugged from the all outlet.Rpt(radiopharmaceutical therapy) was removed from service and later recovered by facilities staff member.Investigation found that the outlet overheated due to user error: power of the rpt(radiopharmaceutical therapy) output was exceeded; high power requirement item was plugged incorrectly.

• Brand Name: TRIPPLITE POWER OUTLET, POWER TAP
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): EATON CORPORATION
• MDR Report Key: 16790776
• MDR Text Key: 313842264
• Report Number: MW5116905
• 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: 04/18/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: PS-415-HG-OEM UL 1363A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White