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

Model Number 8603800

Device Problems Failure to Deliver (2338); Insufficient Information (3190)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device turned off during use.There was no patient injury was reported.

Event Description

It was reported that the device turned off during use.There was no patient injury was reported.

Manufacturer Narrative

This is a correction of the previous report.The model no.Was corrected.As the affected primus, serial no.(b)(6), was produced in march 2014, a unique device identifier (udi) is not required.

Event Description

It was reported that the device turned off during use.There was no patient injury reported.

Manufacturer Narrative

For the investigation the logfile was requested but not provided.As reported, on site the battery was found to be the root cause for the described problem and was replaced.However, the customer chose not to involve the draeger service and therefore, further information about the battery status or even the battery itself were not available for investigation.In case of a power supply failure, the device is designed to continue operation using the internal backup batteries without limitation of functionality while a power failure alarm is given.The remaining capacity of the batteries is indicated to the user and additional warnings are given when the residual battery capacity underruns 20% respectively 10%.Charging level of the batteries always will be shown on the display and should be observed by the user.Further the device checks the batteries during start up phase.In case of a battery failure or a deeply discharged battery during startup an alarm is generated.In case of a failed battery during power up the battery charging level will be marked as 0%.With connected mains power cable it will be possible to use the device but in case of an loss of mains power the device will switch off immediately.Manual ventilation in man/spont-mode and switched off-state remains possible.Dräger has qualified the corresponding rechargeable batteries for use with the devices of the primus family.Due to the different characteristics of batteries from different manufacturers, dräger can only ensure that the specified properties are met with these approved batteries.When replacing the batteries, it must be ensured that no other third-party batteries are used.The batteries are subject to an aging process and are replaced periodically during product maintenance.As no dräger service is involved for maintenance at this customer, it is unclear when the batteries were replaced the last time and if the batteries were approved ones.Finally, it was not possible to identify the root cause for the described issue.The number of similar cases, related to similar issues, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

• 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 ; 9783798000
• MDR Report Key: 18365848
• MDR Text Key: 331008009
• Report Number: 9611500-2023-00504
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8603800
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 06/06/2024; 08/30/2024
• Supplement Dates FDA Received: 07/17/2024; 09/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• 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