MAUDE Adverse Event Report: POM MEDICAL, LLC. POM; POM 1001-MM

Model Number 301-0318LT

Device Problems Disconnection (1171); Nonstandard Device (1420); Obstruction of Flow (2423)

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

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Despite that there was no patient illness, injury or death for this complaint, the manufacturer is filing a mdr due to the corrective actions taken related to this product problem and the formal decision to voluntary recall product on july 11, 2018.

Event Description

As noted by the complainant, when the oxygen line is connected to the high concentration adapter with re-breather bag, the oxygen line "pops off" after the oxygen is turned on due to a clogged port.

• Brand Name: POM
• Type of Device: POM 1001-MM
• Manufacturer (Section D): POM MEDICAL, LLC.; 11959 discovery ct.; moorpark CA 93021
• Manufacturer (Section G): POM MEDICAL, LLC; 11959 discovery ct.; moorpark CA 93021
• Manufacturer Contact: james voss ; 11959 discovery ct.; moorpark, CA 93021 ; 8053062105
• MDR Report Key: 7781002
• MDR Text Key: 117166210
• Report Number: 3010411911-2018-00004
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2021
• Device Model Number: 301-0318LT
• Device Lot Number: 032618-032621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1