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

Catalog Number 8605310

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported there was a ventilator failure.No patient injury reported.

Event Description

It was reported there was a ventilator failure.No patient injury reported.

Manufacturer Narrative

The hospital's biomed has examined the log file in follow-up of the event and - based on the error codes found therein - decided to replace the ventilator motor unit.Reportedly, the device passed all consecutive tests and could be returned to use without further problems reported to date.The biomed provided a screenshot of the error log.It can be confirmed that that the supervisor function detected a wrong motor position and forced a shut-down of automatic ventilation during the particular surgery.This is accompanied by corresponding vent fail alarm; manual ventilation with the built-in breathing bag will be possible and, the monitoring functions remain unaffected.It can be concluded that replacement of the ventilator motor unit was an appropriate measure to put back the device into fully operable condition.The particular anesthesia device was in operation for 15 years now.It is seen likely that wear-and-tear related abrasion of the collector disc has led to intermittent contact loss to the carbon brushes which resulted in speed fluctuations.These speed fluctuations may cause potentially hazardous output or severe mechanical damanges o the ventilator unit and thus, the device is designed to force a safety shut-down of automatic ventilation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported there was a ventilator failure.No patient injury reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12341218
• MDR Text Key: 268671439
• Report Number: 9611500-2021-00349
• 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,Followup
• Report Date: 08/05/2021,05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8605310
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 08/05/2021
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 08/11/2021; 08/11/2021
• Supplement Dates FDA Received: 10/01/2021; 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2006
• 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