MAUDE Adverse Event Report: MASIMO - 40 PARKER PRONTO SPOT CHECK PULSE CO-OXIMETER

Model Number	25764
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the local facility, but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported the display is missing a digit.No patient impact or consequences were reported.
Event or Problem Description
The customer reported the display is missing a digit.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Returned device was evaluated.External visual inspection showed no damage.The device was able to power on using the returned batteries.When powered on one led segment did not illuminate.The un-illuminated segment was not found to be part of the numeric display, and is unlikely to impact the interpretation of any provided measurement.The device was able to obtain readings and alarmed audibly and visually under alarm conditions.Internal inspection showed multiple signs of contamination damage on the system circuit board.The contamination damage to the system board cause the led segment to not illuminate on power up.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).

• Brand Name: PRONTO SPOT CHECK PULSE CO-OXIMETER
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 8645948
• Report Number: 2031172-2019-00267
• Device Sequence Number: 16557923
• Product Code: DQA
• UDI-Device Identifier: 00843997008921
• UDI-Public: 00843997008921
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K091057
• 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
• Report Date (Section B): 05/08/2019

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: Health Professional
• Device Model Number: 25764
• Device Catalogue Number: 9167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RAINBOW DCI MINI SENSOR; RC-1 CABLE; RAINBOW DCI MINI SENSOR; RC-1 CABLE