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

Catalog Number 8607500

Device Problems Circuit Failure (1089); Gas Output Problem (1266); No Device Output (1435); Failure to Deliver (2338)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

It was reported that the primusie changed to safety mode during operation.No injury was reported.

Manufacturer Narrative

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

Manufacturer Narrative

For the investigation the device was analysed and the pcb mobi 3 was determined to be the cause of the reported problem.Its investigation in the laboratory revealed a faulty microprocessor, which is responsible for communication between the components of the device.The exact failure mechanism could not be determined because the logbook cannot be downloaded in the present failure case.In the event of a device failure, automatic ventilation, fresh gas dosing and monitoring functions are no longer available.Manual ventilation is still available.The printed circuit board was replaced and the unit was checked according to manufacturer's specification.No further deviations were found.The number of similar cases due to the same cause is within the expected range of the respective risk assessment and is therefore accepted.The field failure rate of the affected component is subject to continuous monitoring by the responsible prodcut quality board and is assessed as acceptable.

Event Description

It was repoerted that the primusie changed to safety mode during operation.No injury was reported.

• Brand Name: PRIMUS IE
• 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: 15578784
• MDR Text Key: 307181780
• Report Number: 9611500-2022-00272
• 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
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• 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