DISPOSABLE MULTI ABSORBER 8003138

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-02-29 for DISPOSABLE MULTI ABSORBER 8003138 manufactured by Ge Healthcare Finland Oy.

Event Text Entries

[797063] Customer reported difficulty ventilating the pt. There was no reported pt injury. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610105-2008-00007
• MDR Report Key: 1007450
• Report Source: 05
• Date Received: 2008-02-29
• Date of Report: 2008-02-29
• Date of Event: 2007-11-06
• Date Mfgr Received: 2007-11-06
• Date Added to Maude: 2008-06-02
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: ANN LEBAR
• Manufacturer Street: 9900 INNOVATION DR MAIL STOP: RP2138
• Manufacturer City: WAUWATOSA WI 53226
• Manufacturer Country: US
• Manufacturer Postal: 53226
• Manufacturer Phone: 4147213947
• Manufacturer G1: GE HEALTHCARE FINLAND OY
• Manufacturer City: HELSINKI
• Manufacturer Country: FI
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DISPOSABLE MULTI ABSORBER
• Generic Name: NONE
• Product Code: BSF
• Date Received: 2008-02-29
• Model Number: 8003138
• Lot Number: 782067
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 1004245
• Manufacturer: GE HEALTHCARE FINLAND OY
• Manufacturer Address: HELSINKI FI

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-02-29