MAUDE Adverse Event Report: INVIVO CORPORATION XPER INFORMATION MANAGEMENT SYSTEM PM5; PHYSIOMONITORING AND INFORMATION SYSTEM

Model Number 452230034941

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the alarming system is not functioning.Additional information received indicated that there was no alarm sound, but in case deviation values starts to blink.There was no reported patient impact / injury.

Manufacturer Narrative

H10: according to case notes, a philips field service engineer (fse) was dispatched.However, due to the covid-19 curfew in place no onsite visit occurred.Once the curfew has been lifted, an onsite visit will be scheduled.The customer has been notified and is currently using a spare system in the interim.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: XPER INFORMATION MANAGEMENT SYSTEM PM5
• Type of Device: PHYSIOMONITORING AND INFORMATION SYSTEM
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 9874500
• MDR Text Key: 187936844
• Report Number: 1051786-2020-00017
• Device Sequence Number: 1
• Product Code: MWI
• Combination Product (y/n): N
• PMA/PMN Number: K063840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

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: 452230034941
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1