MAUDE Adverse Event Report: HEINE OPTOTECHNIK GMBH & CO.KG STANDARD F.O. LARYNGOSCOPE BATTERY HANDLE; LARYNGOSCOPE, RIGID

Model Number F-001.22.860

Device Problem Unexpected Shutdown (4019)

Patient Problem Bradycardia (1751)

Event Date 10/12/2020

Event Type  Death  

Manufacturer Narrative

Narrative regarding the acknowledgment: gathering pms data, heine optotechnik gmbh & co.Kg (heine) searched for reported incidents in the maude database under the general keyword "heine".The search has been executed on 07/20/2022.This is the date heine became aware of the reported incident.A user facility reported a death involving the heine laryngoscope handle with ref no.F-001.22.860.Heine did not receive a copy of the user facility report, which has been sent to the us agent on b)(6) 2020 by the fda.Therefore, heine did not react with regards to the user facility initial report filed on 10/29/2020 / report #(b)(4) up to now.To get in contact with the user facility (initial reporter), heine has contact fda and asked if resending the user facility report is possible.Immediate actions and investigation started on (b)(6) 2022.Narrative regarding the report duration: due to problems with setting up the webtrader production account, the initial report has already been submitted by sending an email to "dice" on (b)(6) 2022.A subsequent submission via the emdr submission with the description of the circumstance was requested.

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.

Manufacturer Narrative

Narrative regarding the acknowledgment: gathering pms data, heine optotechnik gmbh & co.Kg (heine) searched for reported incidents in the maude database under the general keyword "heine".The search has been executed on 07/20/2022.This is the date heine became aware of the reported incident.A user facility reported a death involving the heine laryngoscope handle with ref no.F-001.22.860.Heine did not receive a copy of the user facility report, which has been sent to the us agent on 11/04/2020 by the fda.Therefore, heine did not react with regards to the user facility initial report filed on 10/29/2020 / report #(b)(6) up to now.To get in contact with the user facility (initial reporter), heine has contact fda and asked if resending the user facility report is possible.Immediate actions and investigation started on 07/20/2022._______________________________________________ narrative regarding the report duration: due to problems with setting up the webtrader production account, the report has already been submitted by sending an email to "dice".A subsequent submission via the emdr submission with the description of the circumstance was requested.________________________________________________ narrative regarding the question, why the event is considered as non-reportable-event: the initial reporter was contacted by heine and the result is summarized below: - the laryngoscope handle or photos weren´t available.- requests for the serial number, light bulb and batteries went unanswered.- the blade (manufacturer, type) used in combination with the heine laryngoscope handle is unknown.- the procedure of the hygienic reprocessing is not known.For this reason, we cannot conduct a detailed technical investigation at our complaint's lab.Analysis of data with reference to complaints, non-conforming products and repairs shows no deviation or trend.To avoid situations that could lead to a dangerous situation or harm, the laryngoscope handle accompanying documents include the following list of warnings and notes that should be considered.When the event occurred, the warnings and notices were already in the accompanying documents.Warnings and notes are laid out in the instruction for use ( med (b)(4)): - only use laryngoscope blades which comply with the "green standard" iso 7376 in conjunction with heine laryngoscope handles.- routinely inspect the condition of the rechargeable battery and xhl bulb and replace them if necessary.- check the correct operation of the device before use! do not use the device if there are visible signs of damage.- use only original heine parts, spare parts, accessories and power sources.- before commencing a clinical application, the state of the internal electrical power source must be tested by turning on the lamp.- we strongly recommend a functional backup of laryngoscopes in an emergency situation.- the hygienic reprocessing only has a minor influence on the product life as this is determined mainly by wear and tear during use.- periodically check the integrity of the device and that the illumination is sufficient! - check the correct function of the device after each rechargeable battery or bulb change.Warnings is laid out in the instruction for hygienic reprocessing (med (b)(4)): - inspection and function testing: perform functional testing after reprocessing.

Event Description

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.__________________________________ what was the original intended procedure? intubating.___________________________________ what problem did the user have? device failed (e.G.Broke, couldn't get it to work or stopped working) ; device malfunction - that is, the device did not do what it was supposed to do.

• Brand Name: STANDARD F.O. LARYNGOSCOPE BATTERY HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): HEINE OPTOTECHNIK GMBH & CO.KG; dornierstrasse 6; gilching, bavaria 82205 ; GM 82205
• Manufacturer (Section G): HEINE OPTOTECHNIK GMBH & CO.KG; dornierstrasse 6; gilching, bavaria 82205 ; GM 82205
• Manufacturer Contact: thomas sauerer ; dornierstrasse 6; gilching, bavaria 82205 ; GM 82205
• MDR Report Key: 16263697
• MDR Text Key: 308361237
• Report Number: 1000379039-2022-00001
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Catalogue Number: F-001.22.860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 82 KG