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

Model Number	2501-7
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: the product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted., additional manufacturing narrative (if other): initial reporter zip code exceeded maximum allowable digits, zip code is as follows: k1h 1e2.
Event or Problem Description
The customer reported sensor intermittently would display values then suddenly no values, no error message.No consequences or impact to patient was reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.The product failed the visual inspection due to a loose bend relief at the sensor end.As a result kevlar and wire jackets were exposed.The sensor passed continuity testing, no open or short connections were detected.When the sensor was connected to a masimo monitoring device, the device was able to generate an error message.The sensor was found to be functioning as designed and the customer complaint was not duplicated.(b)(6).

• Brand Name: M-LNCS DC-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6840666
• Report Number: 2031172-2017-00852
• Device Sequence Number: 19007788
• Product Code: DQA
• UDI-Device Identifier: 00843997003193
• UDI-Public: 00843997003193
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• 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: 2501-7
• Device Catalogue Number: 2501
• Device Lot Number: K17BDJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 09/03/2017
• Supplement Report FDA Received Date: 10/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1