MAUDE Adverse Event Report: TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE, MDI; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	2271418-5
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Bradycardia (1751); Hypoxia (1918)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint products are not available for evaluation.A review of the device history record is not possible as no lot numbers were provided.All information reasonably known as of 14 jul 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that during the time period where the hospital was treating covid patients, there was an issue with disconnection between the closed suction system and the twinstar 90 draëger patient filter (reference (b)(4)).The alleged result of this disconnection was hypoxic bradycardia.Additional information has been requested but not yet received.

• Brand Name: TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE, MDI
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10273012
• Report Number: 8030647-2020-00044
• Device Sequence Number: 811577
• Product Code: BSY
• UDI-Device Identifier: 20609038982636
• UDI-Public: 20609038982636
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2020

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: Health Professional
• Device Model Number: 2271418-5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/14/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1