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

Catalog Number 8607500

Device Problems Failure to Run on Battery (1466); Failure to Deliver (2338); Complete Loss of Power (4015)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

It was reported that a ventilator failure alarm was posted during use.As per report, the users restarted the device whereupon the alarm disappeared and, the device could be further used without restrictions.No patient consequences were resulting from the event.

Manufacturer Narrative

A dräger service engineer was dispatched who checked the device on-site and was unable to duplicate the reported ventilator failure - the device passed all tests without deviations and ventilated in all modes as expected.The log file was evaluated by the manufacturer.It can be confirmed that the device posted a ventilator failure alarm at 07:39 am on the given date of event.The log further indicates that the device ran on battery before until the latter was fully depleted and, the device shut itself off around 07:35 am.Obviusly the users quickly reconnected the device to mains supply afterwards because the device powered-up again and attempted to resume the previously used ventilation mode.This was volume-controlled automatic ventilation in the particular case.Due to the interrupt in ventilation before, the ventilator piston had no position referencing data and, automatic ventilation did not re-start to avoid potential damages to the ventilator unit.The users have then rebooted the device as reported.The reboot procedure includes an automatic piston position referentiation which explains that automatic ventilation was available again after the reboot.The log further indicates that the device had posted a battery low alarm (residual capacity <10%) already at 07:00 am.Dräger concludes that the device behaved as specified during the particular situation - automatic ventilation was not started upon return of electrical energy due to unclear ventilator piston position.Manual ventilation with the built-in breathing bag is still possible.Finally, the case must be attributed to use error - the device clearly indicates when it runs on battery due to missing mains power.The battery depletion alarm was posted more than 30 minutes before the device finally run out of energy and shut down - the users have ignored the warnings.The fact that the device could be operated for >30 minutes after the residual battery capacity underran 10% is exceeding the specified runtime significantly.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18509987
• MDR Text Key: 333321436
• Report Number: 9611500-2024-00011
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675224747
• UDI-Public: (01)04048675224747(11)200506(17)241205(93)8607500-53
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2020
• 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.