MAUDE Adverse Event Report: HEINE USA LTD; TRAY, SURGICAL, INSTRUMENT

Model Number F-001.22.860

Device Problem Environmental Compatibility Problem (2929)

Patient Problems Bradycardia (1751); Death (1802)

Event Date 10/12/2020

Event Type  Death  

Event Description

From staff: doctor was intubating the patient and the light on the laryngoscope was flickering and kept going out.It was difficult to see and had to reintubate twice.Patient had slowed heart rate once intubated and died.

• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): HEINE USA LTD; 10 innovation way; dover NH 03820
• MDR Report Key: 10785849
• MDR Text Key: 214583053
• Report Number: 10785849
• Device Sequence Number: 1
• Product Code: FSM
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F-001.22.860
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 24820 DA
• Patient Weight: 82