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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Initially the reported event was assessed as non-reportable.But based on the investigation results it turned out that during the case in question the peep pressure dropped to ambient due to a restricted automatic ventilation so that in case of recurrence a deterioration in state of health cannot be excluded for patients with difficult lung/ventilation conditions.The electronic logfile was analyzed.The log entries for the reported date of event indicate that the device was not used on a patient on that particular day.The event could rather be reconstructed based on the information stored on the day before.The case in question was started at 11:23am using man/spont.Immediately after switching to automatic ventilation at 11:29 the ventilator detected a too low vacuum pressure and the device reacted as specified by giving the corresponding "reinstall vent" alarm.In this case, automatic ventilation is restricted but manual ventilation as well as monitoring functionality remains unaffected.In the following, the user switched multiple times back and forth between manual and automatic ventilation while the vacuum pressure came back to specified values.The rest of the procedure was unremarkable and stable.At 12:34pm the unit was placed in standby.After the case in question the device was inspected and the vacuum pump was identified to be faulty.Therefore it can be concluded that a sporadic outage of the vacuum pump has caused the reported symptom.The vacuum pump was replaced on-site and the device was tested to specifications afterwards.The apollo was placed back into operation 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.Dräger finally concludes that the device responded appropriately upon the malfunction of a single component after approx.14 years of use.

Event Description

It was reported the staff noticed the apollo being slower and sluggish, but never stopped venting the patient.No patient injury reported.

• Brand Name: APOLLO
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11192738
• MDR Text Key: 228954282
• Report Number: 9611500-2021-00032
• 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
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2006
• 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