MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC UNKNOWN MEDICAL CONSUMABLES AND SENSORS

Model Number	UNK045-MCS
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Philips is in the process of obtaining additional information and the complaint is still under investigation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported ecg leads off alarm did not create an audible alarm on piic ix computer.The device was in clinical use at the time of the reported event.A patient death was reported.
Additional Manufacturer Narrative
The customer reported the ecg electrodes - cab,4 ld,mri ecg,3160 indicating that electrocardiogram (ecg) leads off alarm did not create an audible alarm on the piic ix computer.The patient expired.There were multiple devices involved in this case, the initial complaint (b)(4) addresses the patient information center ix.This complaint was split to address multiple devices involved: complaint (b)(4) addresses the intellivue mx450 patient monitor, and complaint (b)(4) addresses the intellivue x3.The following functional tests were performed: device logs from the pic ix were obtained and investigated as part of initial complaint (b)(4).The rse and customer (biomed) evaluated the sound to make sure it was working properly, both confirmed and verified sound is working.Results of functional testing indicate the audit log showed that the audible alarm was created.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.A clinical harm review was performed and determined the following: the reported event of death was reviewed by the pms clinical expert.This event is assessed as not related to the device in this case.Rationale: per information received from the customer, there was no malfunction of the devices as alarms were generated and speakers were functional.The device was confirmed to be operating per specifications and no failure was identified.The device remains at the customer site.
Event or Problem Description
The customer reported ecg leads off alarm did not create an audible alarm on piic ix computer.The device was in clinical use at the time of the reported event.A patient death was reported.A functional test was performed and the customer biomed along with a philips remote support engineer (rse) confirmed the device produced sound.The device was confirmed to be operating per specifications and no failure was identified.The device remains at the customer site.
Additional Manufacturer Narrative
The report was incorrectly documented as the product was unknown.There is no evidence or allegation in the case referring to a failure of any lead sets and no association to this death.This is not a reportable event with philips.

• Brand Name: UNKNOWN MEDICAL CONSUMABLES AND SENSORS
• Common Device Name: UNKNOWN MEDICAL CONSUMABLES AND SENSORS
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 222 jacobs street; cambridge MA 02141
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 222 jacobs street; cambridge MA 02141
• Manufacturer Contact: deborah currlin ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 15948934
• Report Number: 1051786-2022-00052
• Device Sequence Number: 17769876
• Product Code: MWI
• UDI-Device Identifier: 00884838006386
• UDI-Public: 00884838006386
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K090785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2024

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: UNK045-MCS
• Device Catalogue Number: UNK045-MCS
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022; 12/04/2024
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 01/23/2023; 12/13/2024
• 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: Death
• Patient Sex: Unknown