MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESTHESIA UNITS

Catalog Number 8606500

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not under service contract; the hospital performs maintenance and repair activities on own behalf and responsibility.There was no log file made available which would cover the period in question.The hospital's biomed reported the presence of certain error codes in the logs and that the unit passed a power-on self test which was performed in follow-up of the event without any deviations.The particular error codes indicate that the device did not sense valid breaths during the course of the concerned procedure and thus, alarmed for apnea.It could not be clarified if these were the only error codes that were recorded for the period in question or not.Without the presence of secondary alarms which would point to technical error conditions, the records rather indicate that the device indeed did not stop to ventilate but that ventilation was disturbed by a large external leakage in the patient circuit.This assessment is substantiated by the fact that device passed the test in follow up of the event and did not exhibit any malfunction.However, without having the possibility to analyze the log file, the presence of a technical error condition and the validity of the reportedly observed stop of ventilation cannot be fully ruled out.Hence, this report is being filed in abundance of caution.

Event Description

It was reported that the ventilator stopped ventilating during a case.The patient was bagged and the case was finished.There was no patient injury reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11377126
• MDR Text Key: 245315354
• Report Number: 9611500-2021-00087
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1