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

Catalog Number	MS25755
Medical Device Problem Code	Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The investigation has just startted; results will be provided in a follow-up report.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1220063-2023-00039
• Device Sequence Number: 6789384
• Product Code: MHX
• UDI-Device Identifier: 04049098048989
• UDI-Public: (01)04049098048989
• Combination Product (Y/N): N
• PMA/510(K) Number: K151860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: MS25755
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown