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

Catalog Number 5372

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "item (b)(4) was found to have a deflated mask.Item was on code cart and checked today." no patient involvement was reported.

Manufacturer Narrative

Qn#(b)(4).One (1) 5372 disposable manual resuscitation bag, adult w/flow diverter was received for investigation.Upon visual inspection the complaint was confirmed.The cushion component of the face mask was deflated.Visual examination to include magnified examination has identified three tears in the face mask where air could easily escape from the cushion.All three tears are along the sharp, outer edge of the hard plastic molded mask itself.The tears do not maintain any kind of pattern or similar marking that would be in keeping with a flawed manufacturing process.The physical tears are more in line with an incident associated with operational context.

Event Description

Customer complaint alleges "item 5372 was found to have a deflated mask.Item was on code cart and checked today." no patient involvement was 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: 8236797
• MDR Text Key: 132811683
• Report Number: 3011137372-2019-00030
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/14/2021
• Device Catalogue Number: 5372
• Device Lot Number: 160512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 12/21/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.