MAUDE Adverse Event Report: OWLET BABY CARE INC. OWLET INFANT PULSE OXIMETER

Model Number OBS 1.1

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritability (2421); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 02/17/2018

Event Type  Injury  

Event Description

Parents have used a home pulse oximeter monitor on their (b)(6) old infant's foot since birth.He became very cranky and his mother noted a burn near the ball of his foot, where the sensor is placed.The one inch by one-half inch burn was primarily first degree, with a small second degree in the center.Document number: (b)(4).Report number: (b)(4).

• Brand Name: OWLET INFANT PULSE OXIMETER
• Type of Device: PULSE OXIMETER
• Manufacturer (Section D): OWLET BABY CARE INC.
• MDR Report Key: 7344605
• MDR Text Key: 102748984
• Report Number: MW5075891
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: OBS 1.1
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 MO