MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY KIT, EMMA CAPNOMETER, FULL-ALARM, MMHG; OXIMETER

Model Number 9632

Device Problem High Readings (2459)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer 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 the value is higher than usual.No consequences or impact to patient were reported.

Event Description

The customer reported the value is higher than usual.No consequences or impact to patient were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: the returned device was evaluated.The device was unable to detect an airway adapter and obtain measurements.The unit was zeroed with an airway adapter connected.The unit was able to detect the airway adapter and obtain measurements that were within specification.

• Brand Name: KIT, EMMA CAPNOMETER, FULL-ALARM, MMHG
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: matofa fautua ; 52 discovery; irvine, CA 92618 ; 9498223661
• MDR Report Key: 12564949
• MDR Text Key: 274574490
• Report Number: 3011353843-2021-00263
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9632
• Device Catalogue Number: 9632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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