MAUDE Adverse Event Report: NULL VENTILATORS PNEUPAC ACCESSORIES; ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE

Catalog Number PPPT-BED-SETJP

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Device history record review was completed by the supplier.No product sample was received; therefore, no visual and functional testing could be performed.The reported issue could not be confirmed due to the fact that no samples, pictures or videos were received to perform a thorough investigation.If the product is returned, the manufacturer will reopen this complaint for further investigation.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during a pre-use check, found difficulty in putting a p300 in the basket bed and taking the p300 out of it.Also, the size of the basket bed was found smaller than normal.No patient injury was reported.

• Brand Name: VENTILATORS PNEUPAC ACCESSORIES
• Type of Device: ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRE
• Manufacturer (Section G): NULL
• MDR Report Key: 15401526
• MDR Text Key: 306064614
• Report Number: 3012307300-2022-18633
• Device Sequence Number: 1
• Product Code: BYE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PPPT-BED-SETJP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2022
• 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
• Patient Sequence Number: 1