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

Model Number 560P

Device Problem Degraded (1153)

Patient Problems Anemia (1706); Nerve Damage (1979); Weight Changes (2607); Cancer (3262)

Event Date 01/05/2021

Event Type  Injury  

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam became degraded and caused left lower lobe lung lobectomy for 2 cm cancerous tumor complaint: left thoracic nerve injury with abdominal bulge-permanent, permanent anemia.Left abdominal wall distortion-permanent and a 20 lb weight loss.The patient did report to receive medical intervention and received chemotherapy, cisplatin and alimta.Followed by tagrisso (target medication) for three (3) years.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer previously received information alleging an issue related to a cpap device's sound abatement foam became degraded and caused left lower lobe lung lobectomy for 2 cm cancerous tumor complaint: left thoracic nerve injury with abdominal bulgepermanent, permanent anemia.Left abdominal wall distortion-permanent and a 20 lb weight loss.The patient did report to receive medical intervention and received chemotherapy, cisplatin and alimta.Followed by tagrisso (target medication) for three (3) years.The patient did not report to receive medical intervention.There is no customer information hence we cannot reach out to the customer and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a follow-up report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this follow-up report will be filed.Section h6 updated in this report.

• Brand Name: REMSTAR AUTO A-FLEX
• Type of Device: 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 15206 ; 2673970028
• MDR Report Key: 15268435
• MDR Text Key: 298337710
• Report Number: 2518422-2022-75284
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00606959030497
• UDI-Public: 00606959030497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 560P
• Device Catalogue Number: 560P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other