MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR SE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	220P
Medical Device Problem Codes	Degraded (1153); Fire (1245); Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging of a thermal event to a remstar se device.The user alleges the battery exploded and the device does not retain water.The user was informed by the manufacturer that this device does not contain a battery and questioned user if he was referring to the power supply of the device.The user stated he would send photos, but the photos have yet to be received.The user was requesting a new device.The user alleges there was a burning odor, he saw smoke and heard a loud pop, and then he saw a small flame which had to be extinguished with a little bit of water.The user alleges the back of his headboard on his bed was burnt.There was no evidence of melting or exposed wires.There was no report of patient harm or injury.The device has not returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a thermal event to a remstar se device.The user alleged the battery exploded and the device did not retain water.The user was informed by the manufacturer that this device does not contain a battery and questioned user if he was referring to the power supply of the device.The user stated he would send photos, but the photos have yet to be received.The user was requesting a new device.The user alleges there was a burning odor, he saw smoke and heard a loud pop, and then he saw a small flame which had to be extinguished with a little bit of water.The user alleged the back of his headboard on his bed was burnt.There was no evidence of melting or exposed wires.There was no report of patient harm or injury.Additional information received from the user alleges they did see particles/residue in the device.Section h6, h7, and h9 updated in this report.

• Brand Name: REMSTAR SE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16929726
• Report Number: 2518422-2023-11116
• Device Sequence Number: 12490254
• Product Code: BZD
• UDI-Device Identifier: 00606959038356
• UDI-Public: 00606959038356
• Combination Product (Y/N): N
• PMA/510(K) Number: K130077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup

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
• Operator of Device: Lay User/Patient
• Device Model Number: 220P
• Device Catalogue Number: 220P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic