MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS; ARRHYTHMIA DETECTOR AND ALARM (INCLUDING ST-SEGMENT MEASUREMENT AND ALARM)

Model Number 863310

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer contacted the customer care solution center and alleged an unspecified alarm on the complaint device and requested support.The complaint device was not in clinical use at the time that the issue was discovered.There was no adverse event or patient harm reported.

Manufacturer Narrative

H10: a remote service engineer was dispatched and consulted with the customer and determined that the customer had not installed an sd card into the complaint device.It was confirmed by the rse that the complaint device had not malfunctioned.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.

• Type of Device: ARRHYTHMIA DETECTOR AND ALARM (INCLUDING ST-SEGMENT MEASUREMENT AND ALARM)
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10868024
• MDR Text Key: 218224704
• Report Number: 1218950-2020-07014
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838051294
• UDI-Public: (01)00884838051294
• Combination Product (y/n): N
• PMA/PMN Number: K151812
• 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: 11/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 863310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1