MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY M300; PHYSIOLOGICAL MONITORING SYSTEMS

Catalog Number MS25755

Device Problem Inappropriate Audible Prompt/Feedback (2280)

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

Event Date 09/10/2023

Event Type  malfunction  

Event Description

It was reported that the battery runtime was significantly reduced and that the device was producing false-positive alarms.There was no patient injury associated to that.

Manufacturer Narrative

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

Manufacturer Narrative

The device was tested at the manufacturer's repair center, and it was found that there was a defective (overaged) battery which explains the short run time.Further, the housing as well as the keypad foil exhibited mechanical damages.These damages made the replacement of the entire device necessary; the design does not allow the exchange of individual parts.An in-depth investigation was not considered necessary due to the obvious mechanical damages and the evidence that the aspect of the shortened runtime was clarified.A m300 exchange device has been sent to the customer with factory settings as requested.The involved device was received in a condition with obvious mechanical damages.It could not be clarified if these damages have occurred during the particular monitoring episodes or were present already before.It is under the responsibility and control of the user to inspect the device prior to each use cycle and not to put it into operation if significant deviation such as mechanical damages are observed.The reported reduction of run time could be confirmed and was related to a damaged battery.The battery shall be replaced by trained service personnel in a yearly interval.This wasn't done for the particular device.Hence, it is concluded that lack of maintenance was a contributing factor in the event.

Event Description

It was reported that the battery runtime was significantly reduced and that the device was producing false-positive alarms.There was no patient injury associated to that.

• Brand Name: INFINITY M300
• Type of Device: PHYSIOLOGICAL MONITORING SYSTEMS
• 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 ; 9783798000
• MDR Report Key: 18083735
• MDR Text Key: 327519007
• Report Number: 1220063-2023-00039
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098048989
• UDI-Public: (01)04049098048989
• Combination Product (y/n): N
• PMA/PMN Number: K151860
• 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,Followup
• Report Date: 03/12/2024

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: MS25755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: NA.; NA.