MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2018

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 ventilator failed during use.There was no patient injury reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

The investigation was carried out based on the available information and the analysis of the logfile.It was found, that the device in question was not in operation or connected to a patient on the date of event, neither on july 27th (as initially reported) nor on july 26th (as reported additionally during investigation).In the course of complaint investigation, the user confirmed that the reported event occurred on (b)(6) 2018 at 06:30am during device check i.E.Without patient involvement.Based on the investigation of the logfile, for the whole period covered by the log ((b)(6) 2018), no indications for a ventilator failure during operation were found.On july 26th, there were interactions during device check, which led to a non-availability of the device, indicating a wrong assembly of breathing hoses resulting in no o2 delivery measured at the y-piece.Since sw 2.0x, an optional test can be configured by the user to be part of the self-test of the device.With this test, the potential misalignment of the patient circuit was detected as specified during self-test prior to use.However, there were no indications for a device failure found around the reported date of event.In case of a ventilator failure during operation, automatic ventilation is no longer available.Manual respectively spontaneous ventilation remains possible.If the ventilator fails during self-test, as it was reported additionally for this specific case, the failure will be detected by the device and a message with interactions is displayed with dedicated fault/cause/remedy information.If the test cannot be repeated successfully, the device is not operational.Finally, based on the investigation, no indications for a device failure or a ventilator failure were found.Only a potential misalignment of the patient circuit could be found and this was detected during self-test prior to use.This misalignment led to a non-availability of the device ¿ if the self-test cannot be repeated successfully, the device is not operational.It is possible that this non-availability of the device was interpreted as ventilator failure.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7825784
• MDR Text Key: 118752426
• Report Number: 9611500-2018-00277
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1