MAUDE Adverse Event Report: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT; HEATED AND NON-HEATED BREATHING CIRCUITS

Model Number LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned and evaluation is anticipated, but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that the during the 8-hour operation, the limb-o¿ single limb anesthesia breathing circuit experience a leak test error and no l-shaped connector.There was no impact on patients and medical practice.

Manufacturer Narrative

The suspect device was returned for evaluation, the device history record was reviewed and no issues were found., however, the sample were not evaluated since they are contaminated.Therefore, the root cause was not determined and no corrective or preventive actions will be taken.

• Brand Name: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Type of Device: HEATED AND NON-HEATED BREATHING CIRCUITS
• MDR Report Key: 11807663
• MDR Text Key: 258434968
• Report Number: 8030673-2021-00168
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 10190752122239
• UDI-Public: (01)10190752122239(10)0004145200
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT
• Device Catalogue Number: AFNXXXXX
• Device Lot Number: 0004145200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1