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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Tidal Volume Fluctuations (1634); Gas/Air Leak (2946); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during a case that the device displayed a "re-install ventilator" message.There was no patient injury reported.The patient was bagged and the case was completed.

Manufacturer Narrative

A dräger fse was dispatched who examined the device on-site, could duplicate the reported observation and trace it back to the malfunction of a certain valve.The valve was replaced, the device passed all consecutive tests w/o deviations and it was returned to the facility in ready-to-use condition.The electronic device log file has been evaluated by the manufacturer.The findings derived from the logs are in line with the on-site evaluation results - the ventilator detected a repeatedly occurring expiratory flow during inspiration phases of the particular procedure.The observed reinstall vent alarm is the specified device response for such error condition.The error condition was not yet present in the daily self test done in the morning of the date of event but the next self test that was run on the following day detected the deviation exactly in the test step where the function of the particular valve is being tested that was later replaced.The valve was not available for evaluation and thus, it cannot be determined in detail what exactly led to the occurrence of a leakage while the concerned surgery was under way.The field failure rate of the valve is within accepted range.Dräger finally concludes that the device reacted as specified upon the malfunction of a single component and posted the corresponding alarms.The error condition affected automatic ventilation modes only; manual ventilation was still possible.

Event Description

Please refer to initial mfr.Report.

• 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: 8978584
• MDR Text Key: 157114633
• Report Number: 9611500-2019-00270
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• 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?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other