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

Model Number 2503

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

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 Description

The customer reported inaccurate values.No consequences or impact to patient were reported.

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 Description

The customer reported inaccurate values.No consequences or impact to patient were reported.

• Brand Name: M-LNCS TC-I
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8694190
• MDR Text Key: 147862382
• Report Number: 2031172-2019-00283
• Device Sequence Number: 1
• Product Code: DPZ
• UDI-Device Identifier: 00843997003230
• UDI-Public: 00843997003230
• Combination Product (y/n): N
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1