MAUDE Adverse Event Report: UNKNOWN PULSE OXIMETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Increased Sensitivity (4538)

Event Date 06/24/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, symptoms developed in my right hand, which occurred on the day of the pulse oximeter test performed on my hospital visit, include an acute pain (one-time at night) on the right side of my chest, tingling and needles sensations of the fingers.These symptoms later radiated to my hand.These exact symptoms were affecting my left hand, which i suspected happened from the pulse oximeter test performed on (b)(6) 2022.Both cases were reported to the doctor at my hospital.But i remain concerned about how these safety concerns surrounding this device are documented in the doctor's office/hospital.The fda needs to continue further investigation into the safety, risks and efficacy of this device to avoid a serious and dangerous health impact on consumers/patients.Fda safety report id #(b)(4).

• Brand Name: PULSE OXIMETER
• Type of Device: OXIMETER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15217194
• MDR Text Key: 298088077
• Report Number: MW5111458
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 53 KG