MAUDE Adverse Event Report: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT; BTT

Model Number	900MR810
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ps345699.The complaint 900mr810 adult heated wall reusable breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow-up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in (b)(6) reported that a 900mr810 adult heated wall reusable breathing circuit was damaged.There was no patient involvement.
Additional Manufacturer Narrative
Ps345699.Method: the complaint 900mr810 adult heated wall reusable breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand for evaluation where it was visually inspected.Result: visual inspection of the complaint circuit revealed that the dryline tube was over stretched.Conclusion: the identified damage is most likely due to pulling of the dryline tube.All 900mr810 adult heated wall reusable breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.The complaint device would have met the specification at the time of production.Our user instructions that accompany the 900mr810 adult heated wall reusable breathing circuit state the following: - "inspect circuit before re-use, do not use if the circuit shows signs of deterioration, such as: cracks, tears, or damage." - "perform a pressure and leak test on the breathing system, and check for occlusions, before connecting to a patient." - "disconnect tube by handling end connectors only, do not pull or twist tubing, as this may cause damage.".
Event or Problem Description
A healthcare facility in new york reported that a 900mr810 adult heated wall reusable breathing circuit was damaged.There was no patient involvement.

• Brand Name: ADULT HEATED WALL REUSABLE BREATHING CIRCUIT
• Common Device Name: BTT
• MDR Report Key: 10417819
• Report Number: 9611451-2020-00705
• Device Sequence Number: 2963434
• Product Code: BTT
• UDI-Device Identifier: 09420012432247
• UDI-Public: 010942001243224710210107732
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: Health Professional
• Device Model Number: 900MR810
• Device Catalogue Number: 900MR810
• Device Lot Number: 2101077322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/28/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1