BIPAP AUTO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-03 for BIPAP AUTO * manufactured by Respironics Inc..

Event Text Entries

[5541259] The patient was discharged from the acute care hospital to a skilled nursing facility (snf). The hospital mask was taken along with the patient's home bipap machine. At the snf, the hospital mask was used with the patient's machine. The mask does not provide ventilation of carbon dioxide or moisture and neither did the patient's machine. The patient was found unresponsive with water in the mask. She was hospitalized and had a carbon dioxide level of 172. We looked at hospital masks versus home use masks and do not see any visual indicators on the mask itself that advises against use with other machines. We are going to implement the use of stickers on our masks to say "hospital use only. " ultimately, writing on the mask itself for hospital use only by the manufactures would greatly help. The respiratory department noted that equipment may fit together easily, or it may not but there are all kinds of adapters that can be used so the key would be in a warning on the mask itself.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4534377
• MDR Report Key: 4534377
• Date Received: 2015-02-03
• Date of Report: 2015-02-03
• Date of Event: 2015-01-22
• Report Date: 2015-02-03
• Date Reported to FDA: 2015-02-03
• Date Reported to Mfgr: 2015-02-23
• Date Added to Maude: 2015-02-23
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: BIPAP AUTO
• Generic Name: VENTILATOR
• Product Code: CBK
• Date Received: 2015-02-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESPIRONICS INC.
• Manufacturer Address: 1740 GOLDEN MILE HIGHWAY MONROEVILLE PA 15146 US 15146

Device Sequence Number: 2

• Brand Name: AF531
• Generic Name: VENTILATOR MASK
• Product Code: BSJ
• Date Received: 2015-02-03
• Model Number: *
• Catalog Number: 1072622
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: RESPIRONICS INC.
• Manufacturer Address: 1740 GOLDEN MILE HIGHWAY MONROEVILLE, PA 15146 US 15146

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2015-02-03