MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET DCI; OXIMETER

Model Number 4050

Device Problem Sensing Intermittently (1558)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

The customer reported that spo2 drop outs intermittently.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows:(b)(6).

Manufacturer Narrative

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).

Event Description

The customer reported that spo2 drop outs intermittently.No consequences or impact to patient were reported.

• Brand Name: RD SET DCI
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 16357981
• MDR Text Key: 309331122
• Report Number: 3019388613-2023-00024
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K180046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4050
• Device Catalogue Number: 4050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: RD RAINBOW SET MD20-12; RD RAINBOW SET R25-12