MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY ACUTE CARE SYSTEM (M540); PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number MS25510

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported during a case the m540 nibp was leaking.There was no injury reported.Additionally, there was no interruption in patient care as the unit was immediately swapped out for another m540.

• Brand Name: INFINITY ACUTE CARE SYSTEM (M540)
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 9784828529
• MDR Report Key: 18686755
• MDR Text Key: 335311066
• Report Number: 1220063-2024-00016
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K113798
• 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
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS25510
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2023
• 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