Catalog Number 45372 |
Device Problem
Complete Blockage (1094)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 02/25/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
Customer reported the valves on the device were blocked and as a result the bag could not be compressed.It was reported "increased pressure was applied on the bag and thus the valves opened again and the functionality was given".The issue was discovered prior to use and another device was available for patient use.No patient harm or consequence reported.Patient reported to be "fine".
|
|
Manufacturer Narrative
|
Qn#(b)(4).The sample was returned and sent to the manufacturer (galemed) for investigation.Galemed reports a visual exam was performed and it was observed that the duckbill valve could not be fully opened.It was also reported that a 100% inspection on cosmetic and inspiratory and expiratory resistance tests were given at the assembly line; thus, any defect would be detected prior to release from the manufacturing facility.It was determined that the duckbill valve became sticky during the transportation and storage by accident.
|
|
Event Description
|
Customer reported the valves on the device were blocked and as a result the bag could not be compressed.It was reported "increased pressure was applied on the bag and thus the valves opened again and the functionality was given".The issue was discovered prior to use and another device was available for patient use.No patient harm or consequence reported.Patient reported to be "fine".
|
|
Search Alerts/Recalls
|