MAUDE Adverse Event Report: AMBU A/S AMBU AVIEW 2 ADVANCE

Catalog Number	405011000
Medical Device Problem Codes	Battery Problem (2885); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information from the customer, the housing of the monitor has bulged.They reported that the battery has inflated and burst the monitor.Pictures were delivered for the investigation.
Additional Manufacturer Narrative
The investigation hs not been finalized yet.If the battery has inflated /swelled as informed by the customer, this is a potential fire hazard as gases can build up inside the battery.A follow-up report will be submitted when the investigation has been completed.
Additional Manufacturer Narrative
Initial report on june 12th, 2024: the investigation hs not been finalized yet.If the battery has inflated/swelled as informed by the customer, this is a potential fire hazard as gases can build up inside the battery.A follow-up report will be submitted when the investigation has been completed.Follow-up report #1 on july 2nd, 2024: the preliminary investigation shows a fracture problem and no issues detected for the battery.The battery was intact and not impacted.Investigation has not been finalized.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
According to the information from the customer, the housing of the monitor has bulged.They reported that the battery has inflated and burst the monitor.Pictures were delivered for the investigation.
Additional Manufacturer Narrative
Initial report june 12th, 2024: the investigation hs not been finalized yet.If the battery has inflated /swelled as informed by the customer, this is a potential fire hazard as gases can build up inside the battery.A follow-up report will be submitted when the investigation has been completed.Follow-up report #1, july 2nd, 2024: the preliminary investigation shows a fracture problem and no issues detected for the battery.The battery was intact and not impacted.Investigation has not been finalized.A follow-up report will be submitted when the investigation has been completed.Follow-up report #2, october 2nd, 2024: d4: serial number added.Udi related data quality updates.Only primary di number included, no pi number, as lot is unknown.G3: date updated to reflect when was the new conclusion provided by the investigation h6: c and d codes updated.H10: related report number added.The investigation was done on the actual/suspected device that was made available by the customer.Investigation results showed that the reported failure of battery swelling had not occurred and by corollary that there was no corresponding cause.It is suspected that the user dropped the displaying unit, causing the lcd-panel to slightly detach and move out of the casing.This was misinterpreted by the user as a sign of battery swelling.Based on this findings, the incident is no longer considered reportable.
Event or Problem Description
According to the information from the customer, the housing of the monitor has bulged.They reported that the battery has inflated and burst the monitor.Pictures were delivered for the investigation.

• Brand Name: AMBU AVIEW 2 ADVANCE
• Common Device Name: AMBU AVIEW 2 ADVANCE
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): BRITEMED TECHNOLOGY INC.; 3f, no- 306, sec. 1, datong rd; sijhih dist.; new taipei city, 22146 ; TW 22146
• Manufacturer Contact: bolette walldorf ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 19518071
• Report Number: 9610691-2024-00010
• Device Sequence Number: 8337723
• Product Code: FEM
• UDI-Device Identifier: 05707480145089
• UDI-Public: 05707480145089
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

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
• Device Catalogue Number: 405011000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/13/2024; 09/19/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/02/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown