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

Catalog Number 8603800

Device Problem Insufficient Information (3190)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that the device screen was suddenly turning black making its replacement necessary.It was mentioned in the reported that this did not lead to consequences for the patient.

Manufacturer Narrative

The user facility did not involve the local dräger s&s organization into any follow-up measures.Hence, a case-specific evaluation is not possible.In fact, the complaint cannot be fully understood since it is not clear if solely the device screen blanked out or if the entire device shut-down.A shut-down would not necessarily be related to device malfunction - it can also be the consequence of a combination of environmental facors, use error or maintenance problem such as shut-down due to mains power loss and depleted/worn internal battery.The device is not under a service contract, state of preventive maintenance is unknown to dräger.The unit was in operation for 7.5 years now whereby a material or manufacturing defect is rather to be excluded.The device design allows manual ventilation with the built-in breathing bag including gas dosage even in switch-off state which allows that patient support can at least be bridged until a replacement device was made available.Further conclusions are not possible due to lack of information.It is recommended to the hospital to have the device checked by trained sewrvice personnel.H3 other text : device not available for evaluation.

• 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: 18911724
• MDR Text Key: 337741741
• Report Number: 9611500-2024-00112
• 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
• Type of Report: Initial
• Report Date: 03/15/2024

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 Catalogue Number: 8603800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1