MAUDE Adverse Event Report: MASIMO - 40 PARKER USPO2 PULSE OXIMETRY CABLE KIT; OXIMETER

Model Number 3577

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2018

Event Type  malfunction  

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.

Event Description

The customer reported cables are breaking fairly often and they stopped working.No patient impact or consequences were reported.

Manufacturer Narrative

The returned device was evaluated.External visual inspection showed a cut along the length of the outer jacket of the cable.During evaluation, the device passed all functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.

• Brand Name: USPO2 PULSE OXIMETRY CABLE KIT
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.; calzada del oro, no. 2001; parque industrial palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: erica kline ; 52 discovery; irvine, CA 92618-1604 ; 9492977000
• MDR Report Key: 7453247
• MDR Text Key: 106260538
• Report Number: 2031172-2018-00243
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00843997007481
• UDI-Public: 00843997007481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• 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
• Device Operator: Health Professional
• Device Model Number: 3577
• Device Catalogue Number: 3577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/27/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 06/02/2018
• Supplement Dates FDA Received: 06/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1