MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS MP5; PATIENT MONITOR

Model Number M8105A (865024)

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reported that "the patient's heart stopped for 8 seconds and the mp5 did not alarm at all".The device was used for monitoring at the time of the alleged malfunction.The heart of the (b)(6) year-old male patient with a weight of (b)(6) kilos stopped beating for 8 seconds and then started beating again without medical intervention.The customer's biomedical engineer stated that the patient was fine after the occurrence.No death or patient injury or harm was reported.

• Brand Name: MP5
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 7498406
• MDR Text Key: 107839320
• Report Number: 9610816-2018-00112
• Device Sequence Number: 1
• Product Code: BZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8105A (865024)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 86