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

Model Number	4051
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturing narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.(b)(6).
Event or Problem Description
The customer reported that 6 additional rd dcis were not working.This customer has had previous complaints about rd dcis breaking down much more quickly than the lncs equivalent.Per the customer: "ironically, we found out that 2 more non-disposable probes were not working yesterday after a medical emergency of a patient seizuring in our adjacent xray department.Staff were getting frustrated as they had 3 monitors and 3 different sat probes that there were trying to use to get an oximetry reading.After much time and delay, it was determined that 2 of the 3 probes were not working.They lit up but did not register a reading.I think i have 6 here in my office that have not had longevity with us.This clinical situation sure highlighted our challenges with these probes.".

• Brand Name: RD SET DCI-P
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6580005
• Report Number: 2031172-2017-00587
• Device Sequence Number: 115833
• Product Code: DQA
• UDI-Device Identifier: 00843997009850
• UDI-Public: (01)00843997009850(11)170201(10)R17BXK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4051
• Device Catalogue Number: 4051
• Device Lot Number: R17BXK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Initial Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other