MAUDE Adverse Event Report: PRECISION MEDICAL, INC. TRI-ANIM AIR OXYGEN BLENDER SMALL; PRECISION MEDICAL OXYGEN REGULATOR

Model Number FOTA1000

Device Problems Improper Flow or Infusion (2954); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint device was returned for evaluation.Device sent in due to the bleeder leaking more than normal.Incoming visual inspection found no anomalies.Technical visual inspection found no anomalies.Device evaluation found the device needed a completed overhaul and required re-calibrating.The overhaul was completed and the device was calibrated to oem specification.The root cause was determined to be aged parts.This type of event will continue to be monitored.

Event Description

Reportedly, post repair the bleeder leaks more than normal.It is unknown if there was patient involvement.There was no patient harm reported.No additional information is available.

• Brand Name: TRI-ANIM AIR OXYGEN BLENDER SMALL
• Type of Device: PRECISION MEDICAL OXYGEN REGULATOR
• Manufacturer (Section D): PRECISION MEDICAL, INC.; 300 held dr.; northampton PA 18067
• Manufacturer (Section G): AVANTE HEALTH SOLUTIONS; 212 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: jenna vargas ; 212 avenida fabricante; san clemente, CA 92672 ; 8004495328
• MDR Report Key: 9219344
• MDR Text Key: 178002586
• Report Number: 3007409280-2019-00045
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FOTA1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• 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