MAUDE Adverse Event Report: GALEMED CORP. BABI PLUS 12.5CM H2O PRESSURE RELIEF MANIFOLD; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number BABI.PLUS

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Recalled product seemed to have been tampered with.The original lot number on the outside of the packaging as a new label placed over the original lot number, which reflects product that have been recalled.Upon further examination the lot number on the product inside the package does reflect the new label placed over the old lot number.It seems new product was placed in old bags.

• Brand Name: BABI PLUS 12.5CM H2O PRESSURE RELIEF MANIFOLD
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): GALEMED CORP. ; 87 li-gong 2nd rd; wu-ja ; TW
• MDR Report Key: 9266284
• MDR Text Key: 165093883
• Report Number: MW5090825
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/15/2022
• Device Model Number: BABI.PLUS
• Device Catalogue Number: 1030
• Device Lot Number: 190215/190610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1