MAUDE Adverse Event Report: PRECISION MEDICAL INC. PRECISION MEDICAL INC.; AIR-OXYGEN BLENDER

Model Number	PM5300
Medical Device Problem Codes	No Audible Prompt/Feedback (2282); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Nicu rn reported that the blender gas supply imbalance alarm was not alarming properly and advised there was a patient incident.The baby was transported to nicu without proper oxygen resulting in the baby being hypoxic until arrival and stabilization in nicu.Blender was tested and the reported problem was reproduced - removed device from service.After further testing, an additional three units have been found with the same problem.
Additional Manufacturer Narrative
4 (b)(4) blenders returned for investigation on rga 90640 and tested to bln010, rev 62 and results recorded on dhr.For each of the four (4) units, all performance criteria was within allowable tolerance excluding the audibility of the alarm.Further visual observation showed the alarm reed plates (p/n: (b)(4)) were damaged, extended (bent) beyond functionality.A test protocol was developed and implemented to confirm operation of the reed plate (p/n: (b)(4)) at various pressure exposures.These results conclude that the alarm reed plate is fully functional and activated as expected when operated within published limits.Operating in excess of such limits produced audible failure and physical damage identical to the subjects of this investigation.

• Brand Name: PRECISION MEDICAL INC.
• Common Device Name: AIR-OXYGEN BLENDER
• Manufacturer (Section D): PRECISION MEDICAL INC.; 300 held drive; northampton PA 18067
• Manufacturer (Section G): PRECISION MEDICAL INC.; 300 held drive; northampton PA 18067
• Manufacturer Contact: lisa whitman ; 300 held drive; northampton, PA 18067 ; 6102626090
• MDR Report Key: 16469217
• Report Number: 2523148-2023-00003
• Device Sequence Number: 17458816
• Product Code: BZR
• UDI-Device Identifier: 00855887006016
• UDI-Public: 00855887006016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K053232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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 Model Number: PM5300
• Device Catalogue Number: PM5300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown