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

Model Number M8105A (865024)

Device Problem Delayed Alarm (1011)

Patient Problem Tachycardia (2095)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that "according to the caregiver, there was a tachycardia which began at 09:28 on (b)(6) 2019, but the tachycardia alarm was emitted at 09:33." no death or patient injury or harm was reported.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: MP5
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9178640
• MDR Text Key: 176954931
• Report Number: 9610816-2019-00265
• Device Sequence Number: 1
• Product Code: BZQ
• Combination Product (y/n): N
• PMA/PMN Number: K091395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1