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

Catalog Number 8606500

Device Problems Failure to Deliver (2338); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing.The results will be provided with a follow-up report.

Event Description

It was reported the user received a "reinstall vent" displayed during use.Unable to ventilate automatically.There was no patient injury reported.

Manufacturer Narrative

The reported "reinstall vent" alarm could be confirmed based on the log analysis.It indicates a restricted ventilation capacity of the ventilator.Manual ventilation as well as monitoring functionality is not affected by this failure.During the case in question the ventilator repeatedly detected a too low (negative) vacuum pressure inside the ventilator piston being root cause for the reported "reinstall vent" alarms.The root cause for a vacuum pressure out of specification is manifold and could not be derived from the records.In general a leaky upper and/or lower diaphragm of the ventilator, a faulty vacuum pump or a faulty vacuum pressure valve are possible explanations for the reported failure.The upper diaphragm is part of the 1 year and the lower diaphragm is part of the 3 years maintenance kit, as the material is exposed to deterioration and mechanical stress.The field failure rates of the diaphragms of the ventilator, vacuum pump and the vacuum pressure valve are within the expected range of the respective risk assessment and thus accepted.Besides the "reinstall vent" entries minute volume leaks of up to 5.9 l/min were measured indicating an external leakage in the patient circuit.A high system leakage was already detected during the matutinal post (power-on self-test) but was accepted by the user.During the device check performed after the event a large leak in the inspiratory elbow was detected probably being root cause for the massive leak.As specified for the detected situation "apnea" alarms were posted several times.It can be assumed that the external leakage has also contributed to the impression of the user that ventilation was not possible.

Event Description

It was reported the user received a "reinstall vent" displayed during use.Unable to ventilate automatically.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
• MDR Report Key: 11397396
• MDR Text Key: 234246725
• Report Number: 9611500-2021-00094
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)170818(17)180115(93)8606500-64
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• 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?: Yes
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1