MAUDE Adverse Event Report: MASIMO - 40 PARKER RD SET ADT; OXIMETER

Model Number	4000
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: other, additional manufacturing narrative (if other): the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.The customer address exceeded maximum allowable digits, address is as follows: (b)(6) united states.
Event or Problem Description
It was reported that "anesthesiologist reported only a ¿normal" initial reading of spo2 and then flat line of signal, then observed ¿light went out" ¿ replaced sensor, and it was ¿picking up fine".No error code reported, emitter failed directly after working initially." no known impact or consequence to patient.
Additional Manufacturer Narrative
The returned device was evaluated.During evaluation the unit failed continuity tests due to an open infrared in the emitter assembly.When tested with known good lab equipment a ¿replace sensor" error message was displayed.

• Brand Name: RD SET ADT
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6226242
• Report Number: 2031172-2017-00011
• Device Sequence Number: 735118
• Product Code: DQA
• UDI-Device Identifier: 10843997009567
• UDI-Public: (01)10843997009567(17)190901(10)16JYY
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

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: 4000
• Device Catalogue Number: 4000
• Device Lot Number: 16JYY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 80