MAUDE Adverse Event Report: NEW MERVUE INDUSTRIAL PARK INVOS; OXIMETER, TISSUE SATURATION

Model Number INVOS PRODUCT

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Edema (2020)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, post operative of vascular assist device (vad) implantation, the devices were used for monitoring and had an unknown failure.The customer indicated that on the 5th postoperative day of weaning from a mechanical ventilation, the patient developed pulmonary congestion with respiratory distress, decreased arterial oxygen saturation, and elevated pulmonary artery pressure (pap).

• Brand Name: INVOS
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NEW MERVUE INDUSTRIAL PARK; michael collins road; galway
• Manufacturer (Section G): NEW MERVUE INDUSTRIAL PARK; michael collins road; galway
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8037450
• MDR Text Key: 126088463
• Report Number: 8020893-2018-00531
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INVOS PRODUCT
• Device Catalogue Number: INVOS PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 60