MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PHILIPS INTELLIVUE CAPNOGRAPHY EXTENSION

Model Number	M3014A
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	11/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a multimeasurement server (mms) was attached to a capnography extension.Both were used in companion mode with a intellivue mx700 patient monitor.During use the mms was separated from the capnography extension and fell on the patient's head.The device was in use on a patient at the time of the reported issue.The mms fell on patient's head.The patient underwent a ct scan of the head.No additional information regarding the patient, such as gender, age, height, and weight were provided.
Additional Manufacturer Narrative
A follow up report will be submitted once the investigation is complete.
Event or Problem Description
It was reported that a multimeasurement server (mms) was attached to a capnography extension.Both were used in companion mode with a intellivue mx700 patient monitor.During use the mms was separated from the capnography extension and fell on the patient's head.The mms fell on patient's head.The patient underwent a ct scan of the head.
Additional Manufacturer Narrative
A philips field service engineer (fse) went to the customer site.During the evaluation the fse found that the mms lock was missing and the top cover showed a physical damage.A goods movement indicates a ms_hms mms ext.Lever locks (5ea) (451261012721) + ms_hms mse top cover assy (451261016601) were shipped to the customer to repair and resolve their issue.The product labeling shipped with the device clearly warns that "if the monitor is mechanically damaged, or if it is not working properly, do not use it for any monitoring procedure on a patient.Contact your service personnel." after part(s) replacement the device was returned to functional use with no further issue(s) identified.

• Brand Name: PHILIPS INTELLIVUE CAPNOGRAPHY EXTENSION
• Common Device Name: PHILIPS INTELLIVUE CAPNOGRAPHY EXTENSION
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: derek sammarco ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 12832209
• Report Number: 9610816-2021-10495
• Device Sequence Number: 1362215
• Product Code: MHX
• UDI-Device Identifier: 00884838021549
• UDI-Public: 00884838021549
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K122439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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 Model Number: M3014A
• Device Catalogue Number: M3014A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2009
• 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
• Patient Sex: Unknown