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

Model Number 863380

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The customer reported that the spo2 not reading consistently.A field service engineer (fse) tested the current spo2 probes, after initial reading, the low/high spo2 alarm sound was triggered.The fse changed the finger probe and ear lobe probe and tested again for few minutes; the spo2 was working fine.The device was reported to be in use on a patient, but no adverse event to the patient or user was reported.

Manufacturer Narrative

A follow-up report will be submitted when additional information is received or upon completion of the investigation.

Event Description

Problem statement: the customer reported spo2 not reading consistently.There was no reported patient impact / injury.Complaint evaluation: the field service engineer (fse) tested current spo2 probes, after initial reading low/high spo2 alarm sounds.The fse changed finger probe and ear lobe probe and tested again for few minutes, the spo2 was working fine.Customer resolution and conclusion the probe was replaced which resolved the customer's issue.The serial number for the probe was requested; however, it was reported it is unknown.The device remains at the customer site, and no subsequent calls have been logged for this device/issue.No further action or investigation is warranted based on the available information at the time of complaint closure.Patient/user involvement was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes.Was there any adverse event to the patient or user? if yes, describe? no.If there was an adverse event, did the device cause or contribute to the adverse event, and how? there was no adverse event or patient harm reported.

• 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
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15635832
• MDR Text Key: 302075848
• Report Number: 9610816-2022-00522
• Device Sequence Number: 1
• Product Code: DSJ
• UDI-Device Identifier: 00884838091412
• UDI-Public: 00884838091412
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K190624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• 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