MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER; VENTILATOR, EMERGENCY, MANUAL

Catalog Number 5372

Device Problems Inflation Problem (1310); Device Damaged Prior to Use (2284)

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

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unclear if the device is available for evaluation.Teleflex has requested the device.

Event Description

Report received via medwatch (uf/importer # (b)(4)) states: ambu mask was not inflated coming out of the package during cardiac arrest/cpr event.There was no report of patient harm.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Report received via medwatch (uf/importer #: (b)(4)) states: ambu mask was not inflated coming out of the package during cardiac arrest/cpr event.There was no report of patient harm.

• Brand Name: HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER
• Type of Device: VENTILATOR, EMERGENCY, MANUAL
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8336910
• MDR Text Key: 136614586
• Report Number: 3011137372-2019-00046
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• PMA/PMN Number: K964719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/17/2020
• Device Catalogue Number: 5372
• Device Lot Number: 170830
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Age: 77 YR