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

Catalog Number 5372

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported air was not going through the bag and the bag was hard.The device was being used on an or patient under distress.It was reported that a new bag was obtained and the o2 sats came back up.Patient condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturer (galemed) for investigation.Galemed reports the manufacturing and inspection records were reviewed and no issues related to the reported complaint were found.They also report that during the assembly process 100% functional testing is performed; therefore, any defects would be detected prior to release from the manufacturing facility.It was determined that this product was out of expiration date; therefore, it is considered to be an isolated case.

Event Description

Customer reported air was not going through the bag and the bag was hard.The device was being used on an or patient under distress.It was reported that a new bag was obtained and the o2 sats came back up.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; morrisville NC
• MDR Report Key: 9234615
• MDR Text Key: 190842872
• Report Number: 3011137372-2019-00361
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: 5372
• Device Lot Number: 160919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.