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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Leak/Splash (1354); Mechanical Problem (1384); Failure to Sense (1559); Failure to Deliver (2338); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

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 device posted reinstall vent alarms intermittently.There was no injury reported.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

The electronic logfile was available for investigation.The reported event could be reconstructed by means of the information stored therein.During the case in question, the apollo detected a too low (negative) 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.Based on the evaluation of the logfile, a faulty vacuum pressure sensor pu, placed on the pcb vgc analog, could be determined to be the root cause.On-site, the affected pcb was replaced and the device was tested 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.

• 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: 9621053
• MDR Text Key: 176097399
• Report Number: 9611500-2020-00023
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• 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
• Device Age: YR
• Date Manufacturer Received: 12/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1