MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC ANTIMICROBIAL CUFF, 1 HOSE, ADULT XL (1)

Model Number	M4556B
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	11/17/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported to philips that the a patient died due to blood pressure monitor failure.The device was in use at time of event and patient died.
Additional Manufacturer Narrative
Reporter institution phone number (b)(6).Reporter phone number (b)(6).A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The philips field service engineer (fse) was unable to confirm the event.The fse emailed the customer to gather additional information, but the customer refused further investigation.The cause of the event is unknown.The customer declined service.The device remained on site.

• Brand Name: ANTIMICROBIAL CUFF, 1 HOSE, ADULT XL (1)
• Common Device Name: ANTIMICROBIAL CUFF, 1 HOSE, ADULT XL (1)
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14827988
• Report Number: 1218950-2022-00508
• Device Sequence Number: 14672206
• Product Code: OED
• UDI-Device Identifier: 00884838003125
• UDI-Public: 00884838003125
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K071885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: M4556B
• Device Catalogue Number: M4556B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 12/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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