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

Model Number M1923A

Device Problems Leak/Splash (1354); Tidal Volume Fluctuations (1634)

Patient Problem Respiratory Acidosis (2482)

Event Date 06/01/2019

Event Type  Injury  

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 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.

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
• Type of Device: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8865231
• MDR Text Key: 153407466
• Report Number: 1218950-2019-05801
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 20884838071388
• UDI-Public: (01)20884838071388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1923A
• Device Catalogue Number: 989803105561
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 9 MO