MAUDE Adverse Event Report: PRECISION MEDICAL INC. PRECISION MEDICAL OXYGEN BLENDER

Model Number PM5300

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2018

Event Type  malfunction  

Event Description

Fire incident which occurred to an oxygen blender (5300) in a neonatal intensive care unit.This incident was reported by the hospital personnel to the (b)(6) and a complaint sent to us on (b)(6) 2018.Date of actual occurrence is unknown.

Manufacturer Narrative

[(b)(4)].

Event Description

Fire incident which occurred to an oxygen blender (5300) in a neonatal intensive care unit.This incident was reported by the hospital personnel to the (b)(6) ministry of health and a complaint sent to us on (b)(6) 2018.Date of actual occurrence is unknown.

• Brand Name: PRECISION MEDICAL OXYGEN BLENDER
• Type of Device: BLENDER
• Manufacturer (Section D): PRECISION MEDICAL INC.; 300 held drive; northampton PA 18067
• Manufacturer (Section G): PRECISION MEDICAL INC.; 300 held dr.; northampton PA 18067
• Manufacturer Contact: kathy stackhouse ; 300 held drive; northampton, PA 18067 ; 6102626090
• MDR Report Key: 7682122
• MDR Text Key: 113788663
• Report Number: 2523148-2018-00002
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 00855887006016
• UDI-Public: 00855887006016
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K053232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: PM5300
• Device Catalogue Number: PM5300
• Device Lot Number: 101217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention