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

Catalog Number 8606500

Device Problems Leak/Splash (1354); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

The electronic device log was analyzed.On the reported date of event (b)(6) 2019 the device was powered on at 6:13am.After elimination of a leakage at the mv2 valve the post was passed at 6:29am.The case in question was started at 9:26am using man/spont and was continued in volume mode from 9:36am.Until approximately 10:00am ventilation was unremarkable and stable.In the following minute leaks up to 5.2 l/min were detected, indicating an external leakage in the patient circuit.Consequently a fresh gas deficit arose and several "fg low or leak", "apnea", "mv low" and "volume not attained" alarms were posted.The user switched several times between manual and automatic ventilation while the fresh gas deficit remained present.At 10:18am the unit was placed in standby.Finally based on the available device log records no indications for a product malfunction were found.The ventilator was functional during the whole case and was able to apply volume at any time.Root cause for the reported symptom was a significant leakage in the patient circuit (hose, connector, tube etc.) leading to a loss of pressure and volume and in consequence to a fresh gas deficit.The device has reacted as specified for the detected situation by posting corresponding alarms to inform the user.

Event Description

It was reported that a leak occurred and the ventilator had stopped.The ventilator began to work again however the doctor made the decision to stop the case.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 Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 8447812
• MDR Text Key: 139825667
• Report Number: 9611500-2019-00091
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2010
• 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