MAUDE Adverse Event Report: PENLON INC. PRIMA 460; ANESTHESIA DELIVERY UNIT / GAS - MACHINE, ANESTHESIA

Model Number PRIMA 460

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2019

Event Type  Injury  

Event Description

Prima 460 anesthesia machine became inoperable during surgery.Pt was manually bagged and new machine brought in to operating room.No pt harm.Fda safety report id# (b)(4).

• Brand Name: PRIMA 460
• Type of Device: ANESTHESIA DELIVERY UNIT / GAS - MACHINE, ANESTHESIA
• Manufacturer (Section D): PENLON INC.
• MDR Report Key: 8671121
• MDR Text Key: 147234614
• Report Number: MW5087113
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/30/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR