MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cancer (3262); Solid Tumour (4552)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

The manufacturer received a voluntary medwatch (mw5115595) from an end user¿s caretaker (spouse) alleging her husband underwent a ct scan of the chest which showed a 4.1 x 6.1 cm left lower lobe lung mass as well as enlarged hilar, subcarinal lymph nodes and a very large adrenal metastasis measuring 5.1 cm.He also underwent an endobronchial ultrasound with biopsy through a navigational bronchoscopy with pathology from this revealing a non-small cell lung cancer of adenocarcinoma.An mri of the brain was completed which showed a 2.8 cm left frontoparietal cortical metastasis.Punctate focus of enhancement in the subcortical white marrow on the right parietal lobe was seen as well.Small enhancing lesions were found in each parietal bone.Additionally, he underwent a pet/ct scan that showed intense activity in the left lower lobe lung mass as well as the hilar and mediastinal adenopathy and a 5.5 cm right adrenal mass.He also was found to have lobulated soft tissue masses in the anterior left peritoneal space with intense activity.There were numerous lytic lesions in the bony structures including ribs, liver, cervical spine, lower lumber spine, bony pelvis, proximal femurs, left humerus, and the medial left scapula.The device has not yet been returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported in response to a voluntary medwatch (mw5115595) received from an end user¿s caretaker (spouse) alleging her husband underwent a ct scan of the chest which showed a 4.1 x 6.1 cm left lower lobe lung mass as well as enlarged hilar, subcarinal lymph nodes and a very large adrenal metastasis measuring 5.1 cm.He also underwent an endobronchial ultrasound with biopsy through a navigational bronchoscopy with pathology from this revealing a non-small cell lung cancer of adenocarcinoma.An mri of the brain was completed which showed a 2.8 cm left frontoparietal cortical metastasis.Punctate focus of enhancement in the subcortical white marrow on the right parietal lobe was seen as well.Small enhancing lesions were found in each parietal bone.Additionally, he underwent a pet/ct scan that showed intense activity in the left lower lobe lung mass as well as the hilar and mediastinal adenopathy and a 5.5 cm right adrenal mass.He also was found to have lobulated soft tissue masses in the anterior left peritoneal space with intense activity.There were numerous lytic lesions in the bony structures including ribs, liver, cervical spine, lower lumber spine, bony pelvis, proximal femurs, left humerus, and the medial left scapula.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.

• Brand Name: DREAMSTATION AUTO CPAP
• 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 15208 ; 4125423300
• MDR Report Key: 16782227
• MDR Text Key: 313705983
• Report Number: 2518422-2023-09333
• Device Sequence Number: 1
• Product Code: BZD
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other