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

Catalog Number 5372

Device Problems Device Damaged Prior to Use (2284); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer alleges the device mask seal was found deflated.Alleged issue reported as detected during daily device check.It was reported there was no patient injury or consequence.The patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).One (1) 5372, disposable manual resuscitation, adult w/flow diverter was received for investigation.Upon visual inspection damage was noted on and around the plastic face mask frame which allowed gas to escape from the mask cushion.Functional testing could not be accomplished as the face mask cushion is permanently damaged.The mask deflated due to escaped gases in the mask cushion released when the plastic mask frame was damaged and literally broken in multiple places.This kind of damage could have taken place during use, storage , shipping, or handling.

Event Description

Customer alleges the device mask seal was found deflated.Alleged issue reported as detected during daily device check.It was reported there was no patient injury or consequence.The patient condition was reported as "fine".

• 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
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7658783
• MDR Text Key: 113028302
• Report Number: 3011137372-2018-00186
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964719
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5372
• Device Lot Number: 1534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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