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

Device Problem Insufficient Information (3190)

Patient Problem Skin Burning Sensation (4540)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : ongoing.

Event Description

It was reported that the patient developed a skin irritation or burn mark from the cable of the temperature sensor that was strapped to his cheek for measuring temperature inside the nose.As a side note, it was mentioned that this was already observed on other patients before.

Event Description

It was reported that the patient developed a skin irritation or burn mark from the cable of the temperature sensor that was strapped to his cheek for measuring temperature inside the nose.As a side note, it was mentioned that this was already observed on other patients before.

Manufacturer Narrative

A dräger application specialist has interviewed the users.It was reported that the initial perception of the staff in the ward was that the observation may have been related to any kind of transfer of color pigments from the cable to the skin which explains why the use was continued after the first observations of the phenomenon.But since the marks did not disappear after some days despite intensive cleaning of the skin, the staff concluded that the effect seems rather to be a kind of irritation or burn and informed dräger.As a side note, it was mentioned that the surface of the cables of the temperature probes felt sticky after use.One probe was returned to dräger for evaluation; it turned out that it was not a dräger product.Thus, dräger can only perform a general assessment.Under consideration that the product has obviously produced plausible readings with the iacs, it can be postulated that it did not heat up to a temperature that causes skin burns.Hence, the skin deterioration was likely introduced by a chemical.Another aspect that substantiates this theory is the observation of the sticky cable surface observed by the user - a plausible explanation would be the use of incompatible agents for disinfection which were not cleaned-off afterwards and caused a chemical burn on the patient's skin after contact for several hours/days.It is recommended to the hospital to use dräger probes in combination with the patient monitoring system and to perform a critical review of the reprocessing methods.H3 other text : not a draeger product, not returned.

• 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 ; 9784470587
• MDR Report Key: 18418315
• MDR Text Key: 331593033
• Report Number: 1220063-2023-00061
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: No
• 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