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

Catalog Number MS18596

Device Problem No Visual Prompts/Feedback (4021)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2024

Event Type  malfunction  

Event Description

It was reported by the customer that the delta xl did not alarm when expected to for a specific value.According to the customer, the previous patient may not have been properly discharged, as the delta was needed quickly for another patient, and that the staff noticed an unspecified value on the monitor that they expected to alarm.At one point during the event, the art pressure tube was disconnected with no alarm.

Manufacturer Narrative

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

• Brand Name: 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: 19103099
• MDR Text Key: 340804597
• Report Number: 1220063-2024-00042
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098004169
• UDI-Public: (01)04049098004169(11)070628(93)MS18596-08
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2024

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: MS18596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2007
• 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
• Patient Outcome(s): Other