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

Model Number FR555S

Device Problem Degraded (1153)

Patient Problem Ulcer (2274)

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient reported rashes or pimples in her mouth.There was no report of serious patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported in section b.2.Required intervention to prevent permanent impairment/damage.After review, it was determined no permanent damage was reported , this was incorrectly marked in section b.2.Phone number was updated in section e1, consumer and foreign was marked in g.2.Code 10 was incorrectly marked in section h6.The report should have been sent for product problem only in section b.1.

Manufacturer Narrative

The manufacturer previously marked h10 incorrectly.This mdr was not submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints discovered as part of a retrospective remediation review.

• Brand Name: REMSTAR AUTO
• 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; pittusburg, PA 15206 ; 2673970028
• MDR Report Key: 13844038
• MDR Text Key: 287583472
• Report Number: 2518422-2022-10570
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

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 Model Number: FR555S
• Device Catalogue Number: FR555S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 09/29/2021; 09/29/2021
• Supplement Dates FDA Received: 04/13/2022; 07/12/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/06/2011
• 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