MAUDE Adverse Event Report: LOEWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG LÖWENSTEIN LUISA VENTILATOR; EMERGENCY VENTILATOR

Model Number LM150TD

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Other  

Event Description

Lady on this machine has been found unresponsive at nursing home twice.And has had to have been put ventilator.When she is at hospital on the phillips trilogy 202 she has no problem.

• Brand Name: LÖWENSTEIN LUISA VENTILATOR
• Type of Device: EMERGENCY VENTILATOR
• Manufacturer (Section D): LOEWENSTEIN MEDICAL TECHNOLOGY GMBH + CO. KG
• MDR Report Key: 17634549
• MDR Text Key: 322146026
• Report Number: MW5144993
• Device Sequence Number: 1
• Product Code: QOT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/22/2023

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?: No
• Device Model Number: LM150TD
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2023
• Patient Sequence Number: 1