MAUDE Adverse Event Report: RESPIRONICS, INC. SAMI COMP W/ SS DISP, REUS & PEDS MSK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1082731

Device Problem Fitting Problem (2183)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

The manufacturer received information alleging the device is not coming on.There is no allegation of serious or permanent harm or injury.No medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• Brand Name: SAMI COMP W/ SS DISP, REUS & PEDS MSK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17849342
• MDR Text Key: 324668944
• Report Number: 2518422-2023-25101
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: 1082731
• Device Catalogue Number: 1082731
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1