MAUDE Adverse Event Report: LAERDAL MEDICAL A/S THE BAG II RESUSCITATOR; MANUAL EMERGENCY VENTILATOR

Model Number	THE BAG II
Medical Device Problem Codes	Ambient Temperature Problem (2878); Device Operational Issue (2914); Activation Failure (3270)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user's temperature tested resuscitator has not been returned to the manufacturer for evaluation.
Event or Problem Description
The prehospital service department of a non-us hospital reported the bag ii resuscitator's ability to re-inflate starts to slow at -7 degrees celsius and by -18 c (dfu, minimum operating temp) the ventilation bag does not re-inflate at all; as found during their in-house temperature testing.They reported they have previously submitted several nonconformance reports to their local health authorities for other patient incidents (no details provided) but during these temperature tests no patient was involved nor harmed.

• Brand Name: THE BAG II RESUSCITATOR
• Common Device Name: MANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): LAERDAL MEDICAL A/S; tanke svilandsgate 30; stavanger, N-400 2; NO N-4002
• MDR Report Key: 7251973
• Report Number: 9610483-2018-00002
• Device Sequence Number: 13861325
• Product Code: BTM
• UDI-Device Identifier: 07045432067996
• UDI-Public: 07045432067996
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K132172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/08/2018
• Report Date (Section F): 02/08/2018

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
• Operator of Device: Biomedical Engineer
• Device Model Number: THE BAG II
• Device Catalogue Number: 845211
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/08/2018