MAUDE Adverse Event Report: MASIMO - 40 PARKER M-LNCS TC-I; OXIMETER

Model Number	2503
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.Initial reporter telephone number exceeded the maximum allowable characters, the telephone number is as follows: (b)(6).
Event or Problem Description
The customer reported inaccurate values.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned sensor was evaluated.During evaluation, the cable passed visual inspection; eeprom contents were verified and no problems were observed through this verification.  during continuity testing, the cable failed due to a defective emitter causing low voltage on the red diode.The sensor is functioning, however the low voltage on the red diode caused the spo2 values to fluctuate from 43 to 99%.No stable spo2 measurement value was provided.No issues were detected with regard to pulse rate values.Initial reporter telephone number exceeded the maximum allowable characters, the telephone number is as follows: (b)(6).
Event or Problem Description
The customer reported inaccurate values.No consequences or impact to patient were reported.

• Brand Name: M-LNCS TC-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8694190
• Report Number: 2031172-2019-00283
• Device Sequence Number: 1748157
• Product Code: DPZ
• UDI-Device Identifier: 00843997003230
• UDI-Public: 00843997003230
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: Other
• Device Model Number: 2503
• Device Catalogue Number: 2503
• Device Lot Number: 18FQZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1