MAUDE Adverse Event Report: MMJ SA DE CV (USD) INVOS; OXIMETER, TISSUE SATURATION

Model Number 5100C-EU

Device Problems Device Alarm System (1012); Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device's values were not congruent with the actual state of the patient.It was reported that it did not give alarm when the values were not in the range.There was no allegation of patient death or serious injury.

• Brand Name: INVOS
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 9242277
• MDR Text Key: 164251711
• Report Number: 2936999-2019-00900
• Device Sequence Number: 1
• Product Code: MUD
• UDI-Device Identifier: 10884521211179
• UDI-Public: 10884521211179
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K091224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2019

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
• Device Operator: Health Professional
• Device Model Number: 5100C-EU
• Device Catalogue Number: 5100C-EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/25/2019
• 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