MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA XL; PHYSIOLOGIC MONITORING SYSTEM

Catalog Number MS18596

Device Problem Insufficient Information (3190)

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

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the delta xl display lagged when the rotary knob was used, and that the patient vital display was interrupted and reset.Once the endoscopy case was finished, the delta xl restarted without alarms. the anesthesia machine in use was not impacted, and there was no reported injury or patient death.

Event Description

The customer reported that the delta xl display lagged when the rotary knob was used, and that the patient vital display was interrupted and reset.Once the endoscopy case was finished, the delta xl restarted without alarms. the anesthesia machine in use was not impacted, and there was no reported injury or patient death.

Manufacturer Narrative

A complaint was submitted where it was reported that the delta xl's rotary knob lagged in response, the patient's vital signs were interrupted and there was a shutdown of the monitor.Draeger reviewed the delta xl logs provided and there were no entries found for the reported date of event ((b)(6) 2024).No other logs or information was made available.The mrc repair center in telford found the cause of the delta xl intermittently shutting down was due to a faulty main processor pcb.The board was replaced with an upgraded a107 pcb.Damage to the monitor was addressed by replacing the rear housing, front bezel assembly and the language label.The internal battery and the nibp filters were replaced as a preventative maintenance measure.The rotary knob was not found to be malfunctioning during testing but it was replaced as part of the front bezel assembly.The monitor passed all testing after repair was performed and was cleaned for return to the customer.

• Brand Name: INFINITY DELTA XL
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM
• 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: 19051509
• MDR Text Key: 340343257
• Report Number: 1220063-2024-00039
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098004169
• UDI-Public: (01)04049098004169(11)110629(93)MS18596-34
• Combination Product (y/n): N
• PMA/PMN Number: K152407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS18596
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2011
• 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
• Treatment: N/A.; N/A.
• Patient Outcome(s): Other