MAUDE Adverse Event Report: PALL CORPORATION FALL MEDICAL Q POINT STERILIZING GRADE WATER FILTER; SYSTEM WATER PURIFICATION, GENERAL MEDICAL USE

Model Number QJ212A

Device Problem Increase in Pressure (1491)

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

Event Date 05/12/2018

Event Type  Injury  

Event Description

Point of use water filter used in pt room to control legionella pneumophila appeared to have failed.Mfr believes due to high water pressure event.Mfr inspection (b)(6) 2018.

• Brand Name: FALL MEDICAL Q POINT STERILIZING GRADE WATER FILTER
• Type of Device: SYSTEM WATER PURIFICATION, GENERAL MEDICAL USE
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park drive; port washington NY 11050
• MDR Report Key: 8037885
• MDR Text Key: 126238105
• Report Number: MW5081037
• Device Sequence Number: 1
• Product Code: NHV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2018

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: QJ212A
• Device Catalogue Number: QJ212A
• Device Lot Number: 18-3022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR