MAUDE Adverse Event Report: HUDSON DISP MANUAL RESUS,PED W/FLOW DIVERTER &; VENTILATOR, EMERGENCY, MANUAL

Model Number IPN039348

Device Problem Unintended Deflation (4061)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "the respiratory department is having complaints that the face cushion goes flat and they can not use them".Unknown if the device was in use on a patient at the time of the event.

Manufacturer Narrative

(b)(4).Additional information received indicates the issue was detected prior to use on the patient.The sample was returned and sent to the manufacturer (galemed) for investigation.Galemed reports: "a little air was left in the air cushion, when immerging the mask into the water, we could not see any bubbles leaked from the mask.After long time storage, the air in the cushion will leak naturally.Basing on the limited information (no lot no.) we got at present, we considered that it was a single case.".

Event Description

It was reported "the respiratory department is having complaints that the face cushion goes flat and they can not use them".Unknown if the device was in use on a patient at the time of the event.

• Brand Name: HUDSON DISP MANUAL RESUS,PED W/FLOW DIVERTER &
• Type of Device: VENTILATOR, EMERGENCY, MANUAL
• MDR Report Key: 11344089
• MDR Text Key: 232742338
• Report Number: 3011137372-2021-00026
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 14026704662651
• UDI-Public: 14026704662651
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN039348
• Device Catalogue Number: 5367
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 06/04/2021
• 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
• Treatment: N/A.; N/A.