MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS EARLYVUE; EARLYVUE VS30 VITALS MONITOR

Model Number 863380

Device Problems Defective Component (2292); Device Fell (4014)

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 reported that the device has fallen off the cart and multiple parts are defective.The device was not in clinical use at the time the reported issue was discovered.

Manufacturer Narrative

H10: the customer reported that the mounting screw came off from the vibrations during the transporting of the roll stand and device fell off.The bench repair tech replaced the front panel assembly to repair the device.The roll stand was not returned and therefore could not be further evaluated.A search in salesforce found no further related calls.The absence of further calls supports that the reported problem was resolved.The device remains in use at the customer's facility.No further action or investigation is warranted based on the available information at the time of complaint closure.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: EARLYVUE
• Type of Device: EARLYVUE VS30 VITALS MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 11338508
• MDR Text Key: 233732393
• Report Number: 9610816-2021-00053
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K190624
• 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: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1