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

Catalog Number 8607500

Device Problem Use of Device Problem (1670)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

An engineer of the local dräger s&s organization has checked the device on-site but could not determine any deviation from specification.The log file of the device was submitted to the manufacturer for evaluation.Unfortunately, the period in question was already overwritten; obviously the user facility performed tests in follow-up of the event whereby newer log entries were generated.All in all, the investigation of the reported event remains inconclusive due to missing relevant information and, a reliable explanation for the users' experience cannot be found.Due to the absence of indications for malfunctions it is however seen likely that the reported observation was related to either patient condition or use error.

Event Description

It was reported that the users experienced problems in ventilating the patient at the beginning of a surgical procedure.As per report, the oxygen saturation decreased for a moment but went quickly back to normal after introduction of an alternative ventilation method.No health consequences have reportedly occurred.

• 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
• MDR Report Key: 15318717
• MDR Text Key: 303247654
• Report Number: 9611500-2022-00223
• 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
• Report Date: 08/30/2022

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: 8607500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2017
• 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