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

Catalog Number 8606500

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Urinary Retention (2119); No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported there was a ventilator failure during use on a patient.There was no report of patient injury.

Event Description

Please refer to initial mfr.Report #9611500-2019-00156.

Manufacturer Narrative

A dräger service engineer has examined the device in follow-up of the event.There was no persisting malfunction found and the event could not be duplicated.After having passed the full set of tests the device was returned to use with no further problems reported to date.Log file analysis carried out by the manufacturer revealed the following: the workstation passed the automatic power-on self-test in the morning of the date of event without any deviations.The suspected case was started around 12:00 am system time.The case was stable in regard to ventilation parameter for about 45 minutes.After that the device started to alarm for pinsp not attained and apnea; the ventilator parameter demonstrate that the tidal volumes the ventilator had to apply were partially two times higher than the setting - this is a strong indication for the presence of a large leakage in the pneumatic circuit outside the device.No indication for a potential technical issue was found.Dräger finally concludes that there was/is no issue with the device which would require repair or correction.The device has responded as designed upon a deviation with outside origin, has initiated the defined countermeasures and posted corresponding alarms to alert the user.

• 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: 8635191
• MDR Text Key: 145924954
• Report Number: 9611500-2019-00156
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675229674
• UDI-Public: (01)04048675229674(11)170512(17)171005(93)8606500-64
• 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: 06/21/2019

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/24/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/05/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1