MAUDE Adverse Event Report: INVIVO CORPORATION WIRELESS SP02 MODULE (GEN 2); OXIMETER

Model Number 989803163111

Device Problems Device Emits Odor (1425); Smoking (1585); Excessive Heating (4030)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/25/2019

Event Type  malfunction  

Event Description

While preparing an intensive care unit patient in mri suite, the spo2 module became extremely hot and began to "smoke".The device was immediately removed from the patient and no harm was reported.Staff were first alerted to the malfunction when they smelled burning plastic.Biomedical engineering was contacted and inspected the device.The device has been taken out of service.A replacement module has been placed.

• Brand Name: WIRELESS SP02 MODULE (GEN 2)
• Type of Device: OXIMETER
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research pkwy; orlando FL 32826
• MDR Report Key: 8775559
• MDR Text Key: 150560374
• Report Number: 8775559
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019,02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 989803163111
• Device Catalogue Number: 989803163111
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2019
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Type of Device Usage: N
• Patient Sequence Number: 1