MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED; ANESTHESIA UNITS

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Use of Device Problem (1670); No Apparent Adverse Event (3189)

Patient Problem Cyanosis (1798)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

The investigation was just started, the result will be forwarded in a follow-up report.

Event Description

It was reported that the patient 'turned blue' and it was found the device was not delivering 100% oxygen as selected.A 'no fresh gas alarm' was given.Only 17% oxygen.

Manufacturer Narrative

For the investigation the logfile was analysed.On the reported date of event the case was started using monitoring mode.In monitoring mode no fresh gas is delivered to the ventilator, in the lower left corner of the display (above the gas mixer hardkeys) a no fresh gas supply message appears (no alarm).In the following the device alarmed repeatedly apnea co2, insp.O2 low (measured to 17%) and mv low.Some minutes later o2 started to increase from 17% to 56%.The user obviously used the o2 flush.Subsequently the patient was disconnected from the device.The unit was placed in standby.In the case no fresh gas is provided to the ventilator, ventilation and especially oxygenation of the patient might be restricted.By using the o2 safety flow valve, the user is able to set an adequate fresh gas flow including anesthetic agent, also if the device is switched off.O2-desaturation of patient leads to a critical situation.In general the device alerts with a high priority alarm insp.O2 low.In case of an o2 supply outage, additional alerts for o2 supply pressure low (in case the pipe- or cylinder pressure is too low) and no o2 supply (in case there is no pressure) are given visible and audible (with max.Loudness independent from user settings).The analysis of the electronic logfile has given no hints for malfunction of the device or one of its components during the case in question.The device was tested on site and no technical failures were found, which confirmes the results from the logfile analysis.The ifu provides a detailed description of the monitoring mode.

Event Description

It was reported that the patient 'turned blue' and it was found the device was not delivering 100% oxygen as selected.A 'no fresh gas alarm' was given.Only 17% oxygen.

• Brand Name: PRIMUS INFINITY EMPOWERED
• 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: 13478787
• MDR Text Key: 285217090
• Report Number: 9611500-2022-00038
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 03/22/2022
• Supplement Dates FDA Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2009
• 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.
• Patient Outcome(s): Life Threatening