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

Catalog Number 8606500

Device Problems Decrease in Pressure (1490); Inaccurate Delivery (2339); No Pressure (2994)

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

Event Date 09/04/2022

Event Type  malfunction  

Event Description

It was reported that duriing a case the airway pressure was lost.There was no injury reported.The device reportedly generated an alarm.

Manufacturer Narrative

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

Event Description

It was reported that duriing a case the airway pressure was lost.There was no injury reported.The device reportedly generated an alarm.

Manufacturer Narrative

The electronic log file was available for investigation.The case in question could be reconstructed by means of the information stored therein.Beginning at 5:07pm minute volume leaks of up to 4.4 l/min in the patient circuit were present.The log entries do not indicate a device failure.The device detected the external leak and reacted as specified for such situation as it posted several alarms (e.G.Fresh gas low or leakage, apnea).

• 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: 15645578
• MDR Text Key: 303744533
• Report Number: 9611500-2022-00284
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• 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: 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• 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