MAUDE Adverse Event Report: COVIDIEN ARGYLE ALTITUDE DRY SUCT C D U; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	8888571370
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported they have noticed that the altitude chest drainage system does not maintain suction and the teams report an air leak sound.The patient had to return to the recovery room to change the device.There was no patient injury.
Additional Manufacturer Narrative
The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There is a photo attached to the complaint and this has been reviewed, from this review the manufacturing site cannot confirm the reported issue.Unfortunately, without a physical sample, we are unable to confirm the reported condition.If a sample should be returned later, this complaint will be reopened, and the investigation updated to reflect our findings.Without a physical sample being received, we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).A corrective action is not applicable at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ARGYLE ALTITUDE DRY SUCT C D U
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): COVIDIEN; sragh industrial estate, co, t; offaly ; EI
• MDR Report Key: 10448194
• Report Number: 9611018-2020-00436
• Device Sequence Number: 14464177
• Product Code: GCX
• UDI-Device Identifier: 10884521060975
• UDI-Public: 10884521060975
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: No Information
• Device Model Number: 8888571370
• Device Catalogue Number: 8888571370
• Device Lot Number: 19K307FHX
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1