MAUDE Adverse Event Report: PENLON, INC. PENLON

Model Number PRIMA 460

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 07/18/2017

Event Type  malfunction  

Event Description

Pension anesthesia machine prima 460, av-s display would not power.The unit would not power.Have to contact service for them to remove fuse on vent module and resets it.Then display powers on.

• Brand Name: PENLON
• Type of Device: PENLON
• Manufacturer (Section D): PENLON, INC.; minnetonka MN 55343
• MDR Report Key: 6731289
• MDR Text Key: 80786590
• Report Number: MW5071119
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2017

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: PRIMA 460
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1