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

Model Number	MS18597
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of this investigation.
Event or Problem Description
It was reported that the operator grabbed the monitor by the handle for moving the patient from the induction room to the operating room.During the operation the casing broke and the handle came off the monitor that fell on the operator's foot.After the emergency room visit, where no fractures were found, the operator had a few days of sickness.No specific details regarding any medical intervention/treatment that may have been received at the er was provided.
Additional Manufacturer Narrative
Photos of the damaged device were provided for evaluation.It can be confirmed that the device handle was detached from the chassis and that heavy damage to the housing had resulted from the drop to the floor.No obvious signs of potential pre-damage had been identified and thus, a physical return of the device was not considered meaningful.Details in regard to the used disinfection agents could not be obtained.A clear root cause could not be determined.The device was in operation for 12 years now and, it was determined that the last preventive service inspection was done five years ago.It can thus not be excluded that a pre-damage was already present prior to the occurrence of the particular event.Apart from the recommended check by skilled persons in regular intervals, it is under responsibility and control of the user to inspect the product prior to each use cycle and not to put it into operation if significant deviation such as a damage of the housing can be observed.Post market surveillance data reasonably suggests that the device design is suitable for the typical use conditions; the case is considered a single event.The person whose foot was hit by the falling device was absent from work for some days but no further health consequences were resulting from the event.
Event or Problem Description
It was reported that the operator grabbed the monitor by the handle for moving the patient from the induction room to the operating room.During the operation the casing broke and the handle came off the monitor that fell on the operator's foot.After the emergency room visit, where no fractures were found, the operator had a few days of sickness.No specific details regarding any medical intervention/treatment that may have been received at the er was provided.

• Brand Name: DELTA XL
• Common Device Name: 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: 17406132
• Report Number: 1220063-2023-00024
• Device Sequence Number: 14927734
• Product Code: MHX
• UDI-Device Identifier: 04049098004152
• UDI-Public: 04049098004152
• Combination Product (Y/N): N
• PMA/510(K) Number: K070566
• 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): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MS18597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2011
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female