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

Catalog Number 8606500

Device Problems Failure to Deliver (2338); Insufficient Information (3190)

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

Event Date 11/30/2020

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 failed during a case.There was no patient injury reported.

Manufacturer Narrative

As per report, the hospital's biomed could confirm the ventilator failure during follow-up testing.The ventilator motor as well as the piston diaphragms were replaced; reportedly the device works well after the repair ingress.The replaced parts were discarded, unfortunately.No log file was kept that would cover the period in question.Thus, dräger can neither confirm nor deny the reported event and the causal connection drawn by the biomed.There are multiple conditions that may trigger a safety shutdown of automatic ventilation.These are not necessarily related to component malfunctions.A differentiation is not possible due to lack of information.If automatic ventilation fails, the monitoring functions of the workstation remain unaffected.Manual ventilation with the built-in breathing bag will still be possible which at least allows to bridge patient support until a replacement device is available.

Event Description

It was reported that the unit failed during a case.There was 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
• MDR Report Key: 11484772
• MDR Text Key: 243743439
• Report Number: 9611500-2021-00107
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.