MAUDE Adverse Event Report: PRECISION MEDICAL INC O2 HOSES

Model Number HA-U1C4-01686

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

Precision medical inc evaluated the returned hose assembly which had a fitting that was not drilled out causing no flow.An additional inspection of all fittings was performed resulting in no discrepancies.Review of complaints indicates no other similar complaints.Supplier was notified of the defective component.This incident has been documented in the complaint files for any trending.There was no patient harm.

Event Description

New oxygen high pressure hose was found to be not patent upon first use.Hose was attached to an air/o2 blender.Blender was placed in use in our nicu.Patient safety not affected - as soon as the hoses were plugged in the blender alarmed and they immediately took it out of service and placed the patient on another device.After further investigation the rt supervisor found that the hose was blocked.Blender was not manufactured by precision medical inc.

• Brand Name: O2 HOSES
• Type of Device: O2 HOSES
• Manufacturer (Section D): PRECISION MEDICAL INC; 300 held drive; northampton, pa
• Manufacturer (Section G): PRECISION MEDICAL INC; 300 held drive; northampton, pa
• Manufacturer Contact: brian klotz ; 300 held drive; northampton, pa ; 2626090234
• MDR Report Key: 9856064
• MDR Text Key: 204760277
• Report Number: 2523148-2020-00001
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HA-U1C4-01686
• Device Catalogue Number: HA-U1C4-01686
• Device Lot Number: 02202000081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention