MAUDE Adverse Event Report: PULSE OXIMETER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Asthma (1726)

Event Date 05/07/2021

Event Type  Injury  

Event Description

I went to the hospital due to a severe asthma attack.I was visibly struggling to breathe but was made to wait in the lobby because the hospital was busy and i had normal levels of above 90% according to a pulse oximeter device.I went back to tell them i was literally dying with each breath and they used the device again only to show normal values.After an hour and a half wait i was finally seen and given an arterial blood gas which valued at 57mmgg way below the normal.I had to be put on oxygen for the first time and spent days in the hospital.I can't believe how inaccurate this was and i will never fit get this.

• Brand Name: PULSE OXIMETER
• Type of Device: OXIMETER
• MDR Report Key: 12307836
• MDR Text Key: 266382514
• Report Number: MW5103174
• Device Sequence Number: 1
• Product Code: DQA
• 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: 08/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR