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

Catalog Number 8603800

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); No Flow (2991); Complete Loss of Power (4015)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that during surgical procedure there was an equipment failure.The device turned off during use.No patient injury was reported.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Manufacturer Narrative

Based on the logfile analysis, the case in question could be reconstructed and it was found that a used-up battery has caused the reported shutdown.The case in question was started at 10:11am.At 10:58am, the device alarmed for battery low and in the following, the device switched to man/spont-mode and alarmed ventilator fail accordingly.The case in question was continued in this mode for 3 minutes and then the user performed a power cycle.In case of a power failure, the primus device switches to battery mode automatically.As described in the ifu, the message power fail is displayed on the screen together with the remaining battery capacity in percent.If the battery is almost empty, the message battery low will be given, as it could also be confirmed for the case in question.In the event of a power failure and empty batteries, the primus permits manual ventilation with 100 % o2.The ifu further describes to check the vaporizer settings and to press the safety knob for o2 emergency delivery and to set it to the required o2 flow, this o2 flows through the vaporizer.The batteries are subject to an aging process and are replaced periodically during product maintenance (each 3 years).For further analysis, the battery was requested but was unfortunately not available.Pictures of the battery-set were provided showing the prints on the battery-set.Those showed that the battery was installed after the shelf life of 180 days was expired.A label on the package of the battery-set shows the production- as well as used-by date.Dräger finally concludes that the excess of maximum storage time leading to already pre-damaged batteries when being installed was the root cause of the shutdown during use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that during surgical procedure there was an equipment failure.The device turned off during use.No patient injury was reported.

• Brand Name: PRIMUS
• 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: 18236582
• MDR Text Key: 329355965
• Report Number: 9611500-2023-00433
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2008
• 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