MAUDE Adverse Event Report: FABRICATION ENTERPRISES INC. FEI 12-1926 BASELINE FINGERTIP PULSE OXIMETER, STANDARD

Model Number 12-1926

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2022

Event Type  malfunction  

Event Description

The baseline pulse oximeter display is upside down.A 98% becomes 89%.It was available here: (b)(6).Baseline fingertip pulse oximeter, standard.Fda safety report id# (b)(4).

• Brand Name: FEI 12-1926 BASELINE FINGERTIP PULSE OXIMETER, STANDARD
• Type of Device: OXIMETER
• Manufacturer (Section D): FABRICATION ENTERPRISES INC.; po box 1500; white plains NY 10602
• MDR Report Key: 13334232
• MDR Text Key: 284448800
• Report Number: MW5106902
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/19/2022

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: Lay User/Patient
• Device Model Number: 12-1926
• Device Lot Number: 124617
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2022
• Patient Sequence Number: 1
• Patient Sex: Male