MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EARLYVUE; MULTI-PARAMETER PATIENT MONITOR

Model Number 863380

Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

:the device was returned to philips for evaluation.Due to a change in decontamination processes which also involved a facility change, the device cannot be located.Due to age of the complaint, the case will be closed.If/when the device be located, evaluation of the device will be documented in the defoa database under defoa-2020-08-34124.The customer was sent a replacement device.Reference manufacturer's report number 1218950-2020-04913 previously submitted with incorrect registration number.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.The device was returned to philips but can not be located.

Event Description

The customer reported the problem of speaker malfunction.The device was not in use on a patient.

• Brand Name: EARLYVUE
• Type of Device: MULTI-PARAMETER 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: robert corning ; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11019523
• MDR Text Key: 222326507
• Report Number: 9610816-2020-00456
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00884838091412
• UDI-Public: (01)00884838091412
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2020

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: 863380
• Device Catalogue Number: 863380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: No
• 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