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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); High impedance (1291); Calibration Problem (2890); Device Sensing Problem (2917)

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

Event Date 09/30/2022

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 device alerted the calibration of flow sensors.Further n2o was added on its own, despite no n2o was used.Ventilation did not work as it should and the blood gas analysis showed co2 above 8.No serious patient injury reported.

Event Description

It was reported that the device alerted the calibration of flow sensors.Further n2o was added on its own, despite no n2o was used.Ventilation did not work as it should and the blood gas analysis showed co2 above 8.No serious patient injury reported.

Manufacturer Narrative

Based on the investigation results this case is no longer considered to be reportable.The evaluation of the logfile records revealed that the gas dosage of the electronic gas mixer was accurate.An unintentional administration of n2o as reported could not be confirmed.However, there was an incorrect measurement of the n2o channel by the patient gas measurement module.It was found that the resistor on the pcb of the anesthetic agent sensor became high-impedance being root cause for the identified incorrect measurement.The inspiratory and expiratory gas concentrations are measured permanently.Since the gas readings are not used for control purpose there is no influence on gas dosage or ventilation.A n2o concentration above 82% will be alarmed immediately with an ¿insp.N2o high¿ alarm.Depending on the set alarm limits adjusted by the user additionally an insp.O2 low will be given.Oxygen dosage via the o2 flush as well as the o2 emergency delivery remains possible.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15650850
• MDR Text Key: 302205166
• Report Number: 9611500-2022-00287
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170713(17)180224(93)MK06000-33
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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
• Treatment: NA.; NA.