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 Patient Involvement (2645)

Event Date 01/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "resuscitation bag mask deflated.Unable to use product.It was found on inspection of code carts." no patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual inspection was performed to determine if the sample had sustained any abuse/misuse/ damage.The cushion of the face mask was completely deflated due to a chip in the hard plastic mask itself which compromised the air tight seal at the cushion and the mask.Based on the investigation performed, the reported complaint was confirmed.The plastic face mask was subjected to some kind of force great enough to chip the hard plastic, which in turn caused the leakage.This defect appears as though it could be the result of improper storage, mishandling, or abuse; however, the root cause could not be determined.There is no evidence that points to a manufacturing/assembly process issue.

Event Description

Customer complaint alleges "resuscitation bag mask deflated.Unable to use product.It was found on inspection of code carts." no patient involvement reported.

• 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: 8266569
• MDR Text Key: 133727519
• Report Number: 3011137372-2019-00019
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/10/2020
• Device Catalogue Number: 5372
• Device Lot Number: 171010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.