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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Inaccurate Delivery (2339); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the unit stopped ventilating while on a patient.No injury reported.

Manufacturer Narrative

According to the log file analysis the ventilator detected an expiratory gas flow during inspiration.Thus, the device alarmed for reinstall vent.A temporary, faulty electronic peep valve (mv1) due to a delayed closure of this pneumatic valve can be assumed as root cause.A sticking/stucking peep valve is detected during automatic post.During automatic ventilation, pressure control might be disturbed, as consequence airway pressures, tidal and minute volumes can deviate from user settings.Depending on the set alarm limits, alarms regarding inspiratory pressure and/or tidal/minute volume will be generated, as well as technical alarms like reinstall vent.Manual ventilation and monitoring functions are not affected in this case.

Event Description

It was reported that the unit stopped ventilating while on a patient.No injury reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17841287
• MDR Text Key: 324551920
• Report Number: 9611500-2023-00343
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)190829(17)240206(93)8606500-67
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2019
• 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