MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH APOLLO; ANESTHESIA UNITS

Device Problem Application Program Problem (2880)

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

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

A draeger service technician was dispatched after the event and was not able to reproduce the reported symptom.The technician tested the machine and reported that all tests passed.The electronic log file was provided for further root cause investigation.Based on the device log file records on (b)(6) 2015, the device was powered on at 7:31am.The subsequent power-on self test (post) was successfully completed at 7:35am.The case in question was started at 8:22am using man/spont and continued from 8:29am in volume mode.Just from the beginning the device repeatedly alarmed for apnea and according to the records minute volume leaks up to 10.4 l/min were present.The reported attempts to change the ventilation mode could be reproduced.The log entries indicate that between 8:33am and 8:42am the user switched between man/spont and several automatic ventilation modes multiple times.The situation persisted and several apnea, volume not attained and fg low or leak alarms were given while minute volume leaks up to 16.8 l/min were detected.At 8:42am the leakage problem was obviously resolved as ventilation was stable and unremarkable until the end of the case at 11:03am.The investigation has not revealed a device failure.A significant leakage in the patient circuit was identified as the root cause for the reported symptom.The machine has reportedly been returned to use with no further problems reported to date.

Event Description

It was reported that "the user could not ventilate in manual mode but automatic mode ventilation worked as expected.The machine had reportedly passed the pre-use checks prior to the case.The case was completed and there was no patient injury reported".

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; 53/55 moislinger allee; luebeck 23542 ; GM 23542
• Manufacturer Contact: frank clanzeft ; 53/55 moislinger allee; luebeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4943545
• MDR Text Key: 22394469
• Report Number: 9611500-2015-00133
• 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
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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