O2-RESQ 02RES1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-19 for O2-RESQ 02RES1 manufactured by Pulmodyne.

Event Text Entries

[2562331] O2-resq disposable cpap system by pulmodyne distributed through (b)(4). The existing product is defective: the o2 line going into the filter was not seeded deep enough into the filter causing an air leak, decreasing the air flow that went to the pt. At (b)(6) medical transportation we found 2 lot numbers with the bad product that will be recalled on the national level in case those 2 lot numbers went to other areas across the state. The cpap system is o2resq system bad lot number 1 is 3037035x110513. Bad lot number 2 is 3037035x110624. Dates of use: (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5023928
• MDR Report Key: 2428337
• Date Received: 2012-01-19
• Date of Report: 2012-01-19
• Date of Event: 2012-01-09
• Date Added to Maude: 2012-01-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: O2-RESQ
• Generic Name: CPAP
• Product Code: BYE
• Date Received: 2012-01-19
• Returned To Mfg: 2012-01-20
• Model Number: 02RES1
• Lot Number: 3037035X110513
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PULMODYNE

Device Sequence Number: 2

• Brand Name: O2-RESQ
• Generic Name: CPAP
• Product Code: BYE
• Date Received: 2012-01-19
• Returned To Mfg: 2012-01-20
• Model Number: O2RESQ
• Device Availability: R
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: PULMODYNE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-19