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

Model Number THE BAG II

Device Problems Ambient Temperature Problem (2878); Device Operational Issue (2914); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The user's temperature tested resuscitator has not been returned to the manufacturer for evaluation.

Event 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
• Type of Device: MANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): LAERDAL MEDICAL A/S; tanke svilandsgate 30; stavanger, N-400 2; NO N-4002
• Manufacturer (Section G): LAERDAL MEDICAL A/S; tanke svilandsgate 30; stavanger, N-400 2; NO N-4002
• Manufacturer Contact: donald garrison ; 167 myers corners road; wappingers falls, NY 12590-8840 ; 8452977770
• MDR Report Key: 7251973
• MDR Text Key: 99803623
• Report Number: 9610483-2018-00002
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 07045432067996
• UDI-Public: 07045432067996
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K132172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: THE BAG II
• Device Catalogue Number: 845211
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2018
• Distributor Facility Aware Date: 01/17/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1