Additional manufacturing narrative: other, other text: a total of eight (8) sensors and cables were returned and evaluated.Part#: 4106-9, lot#: 20kge, device manufacturer date: 10/5/2020, unique identifier (udi) #: (b)(4).The cable passed all visual and functional testing.The cable was determined to be functioning as designed.Part#: 4078-9, lot#: 20jdm, device manufacturer date: 10/6/2020, unique identifier (udi) #: (b)(4).The cable passed all visual and functional testing.The cable was determined to be functioning as designed.Part#: 4106-9, lot#: 20kge, device manufacturer date: 10/5/2020, unique identifier (udi) #: (b)(4).An open in cable on the white conductor was observed.The cable failed continuity and functional testing.The host device displayed an error message and audibly and visually alarmed during functional testing.Part#: 4050, lot#: 20j3w, device manufacturer date: 9/29/2020, unique identifier (udi) #: (b)(4), premarket (510k) number: k180046.Testing found contamination at the connector, causing a damaged trace and resulting in the sensor having an open connection.The sensor failed continuity and functional testing.The host device displayed an error message and audibly and visually alarmed during functional testing.Part#:4078-9, lot#: 22ezp, device manufacturer date: 6/3/2022, unique identifier (udi) #: (b)(4).A broken tab from the sensor stuck inside the connector of the cable, preventing the cable to be connected, was observed.Unable to perform continuity and functional testing as a result.Part#: 4050, lot#: 20hwm, device manufacturer date: 8/27/2020, unique identifier (udi) #: (b)(4), premarket (510k) number: k180046.Contamination of the connector was observed.Contamination on pads caused multiple open connections.The sensor failed continuity and functional testing.The host device displayed an error message and audibly and visually alarmed during functional testing.Once the contamination cleaned off, the sensor became able to function as designed.Part#: 4106-9, lot#: 20gax, device manufacturer date: 8/4/2020, unique identifier (udi) #: (b)(4).Broken pin at the round 25 pins connector was observed.The broken pin caused an open connection.The cable failed continuity and functional testing.The host device displayed an error message and audibly and visually alarmed during functional testing.Part#: 4078-9, lot#: 20jdm, device manufacturer date: 10/6/2020, unique identifier (udi) #: (b)(4).A broken tab from the sensor stuck inside the connector of the cable, preventing the cable to be connected, was observed.Unable to perform continuity and functional testing as a result.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
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