MAUDE Adverse Event Report: CHONGQING JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO. PH CAPSULE

Model Number	JSPC-1
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Jinshan evaluated the event based on all information received.The ph capsule was not returned.Testing of products from the same batch confirmed compliance with the specified requirements.The device history record (dhr) for this batch was reviewed and found to comply with the device master record (dmr).A review of complaints over the past three years revealed no incidents of ph capsules entering the trachea.Based on the available information, no cause for the product malfunction could be identified.This report is submitted in compliance with fda regulations 21 cfr parts 803.Jinshan has made reasonable efforts to provide as much relevant information as is available as of the submission date of this report.Neither the submission of this report nor any statement contained herein is intended to be an admission of jinshan, or its employees caused or contributed to the event described in the report.A supplemental report will be submitted if additional relevant information becomes available.
Event or Problem Description
It is reported that upon placing the ph capsule, the probe dislodged in the posterior oropharynx region and was sitting on the vocal cords.As the md attempted to grab the probe with biopsy forceps, the probe advanced into the trachea.Patient was stabilized and intubated.Ems called immediately, ed notified.Ph capsule was removed by sgr hospital.Pt was then discharged from the hospital.

• Brand Name: PH CAPSULE
• Common Device Name: PH CAPSULE
• Manufacturer (Section D): CHONGQING JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO.; no. 18, nishang road,; lianglu industry city, yubei d; chongqing, 40112 0; CH 401120
• Manufacturer (Section G): CHONGQING JINSHAN SCIENCE & TECHNOLOGY (GROUP) CO.; no. 18, nishang road,; lianglu industry city, yubei d; chongqing, 40112 0; CH 401120
• Manufacturer Contact: xin luo ; no. 18, nishang road,; lianglu industry city, yubei district; chongqing, 40112-0 ; CH 401120
• MDR Report Key: 21759613
• Report Number: 3011219572-2025-00001
• Device Sequence Number: 8647928
• Product Code: FFT
• UDI-Device Identifier: 06946332800045
• UDI-Public: (01)06946332800045(17)261108
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/09/2025
• Device Model Number: JSPC-1
• Device Catalogue Number: A1-2001
• Device Lot Number: JSPC0985002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDELA VARIO 18 SUCTION PUMP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White