MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITALS MONITOR

Model Number 863380

Device Problem High Readings (2459)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported the problem of monitor displays too high values.Patient involvement is unknown.

Event Description

The customer reported the problem of the monitor displays too high values.Patient involvement is unknown.There was no reported patient or user impact.

Manufacturer Narrative

The customer contacted the customer care solutions center(ccsc) for troubleshooting/evaluation of the device.According to the email response from 09jun2021, the ccsc stated that this is a time & material repair due to the customer does not have a valid service contract for that system.A service repair quotation was provided to the customer.A good faith effort was made to obtain update information if customer approved the quote, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.H3 other text: a service quotation has been provided to the customer and is pending acceptance.

• Brand Name: EARLYVUE VS30 VITALS MONITOR
• Type of Device: EARLYVUE VS30 VITALS MONITOR
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 11975548
• MDR Text Key: 255405055
• Report Number: 9610816-2021-10160
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• Combination Product (y/n): N
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• 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?: 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
• Distributor Facility Aware Date: 05/28/2021
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/10/2021
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1