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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Improper Flow or Infusion (2954); Pressure Problem (3012)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the unit alarmed for a ventilator error during a case.There was no patient injury reported.

Event Description

It was reported that the unit alarmed for a ventilator error during a case.There was no patient injury reported.

Manufacturer Narrative

During on-site checking in follow-up to the event, the draeger technician found the lower rolling diaphragm being damaged to be the root cause of the reported symptom.Based on the log analysis, it could be confirmed that during the case in question, the device alarmed for reinstall ventilator due to a too low (negative) vacuum pressure in the piston.It could be concluded that the lower diaphragm being damaged caused a leak and thus the low vacuum pressure.The vacuum pressure is traced by a pressure sensor and after falling below the limit of -80 hpa, the device alarmed reinstall ventilator as specified.Finally, it can be concluded that the device responded appropriately upon a deviation in the pneumatic system and posted a corresponding alarm.No patient consequences have occurred.The replacement of the diaphragm has already solved the problem; the device passed all consecutive tests and was returned to use without further problems reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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
• MDR Report Key: 14020425
• MDR Text Key: 297348642
• Report Number: 9611500-2022-00088
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)181206(17)190503(93)8606500-65
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• 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: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• 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