MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS FILTERLINE H SET INFANT/NEONATAL

Model Number	M1923A
Health Effect - Clinical Code	Respiratory Acidosis (2482)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Serial number unknown.A follow-up report will be submitted once the investigation is complete.The customer also reported that the patient improved when the filter line was removed.
Event or Problem Description
The customer stated that the filter line had "excessive leaks of 60%".The excessive leak caused poor tidal volume and acidosis.The customer alleged that the leak caused the patient to become very ill and acidotic on blood gases.
Additional Manufacturer Narrative
The material was discarded and an evaluation could not be completed.This event will be considered as a malfunction of unknown cause with insufficient information.

• Brand Name: FILTERLINE H SET INFANT/NEONATAL
• Common Device Name: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 8865231
• Report Number: 1218950-2019-05801
• Device Sequence Number: 14109550
• Product Code: MKJ
• UDI-Device Identifier: 20884838071388
• UDI-Public: (01)20884838071388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090483
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M1923A
• Device Catalogue Number: 989803105561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 MO