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

Model Number	IPN039348
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem 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.
Additional 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 or Problem 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 &
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL
• MDR Report Key: 11344089
• Report Number: 3011137372-2021-00026
• Device Sequence Number: 4997776
• Product Code: BTM
• UDI-Device Identifier: 14026704662651
• UDI-Public: 14026704662651
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K964719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 06/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.