MAUDE Adverse Event Report: A-DEC, INC. A-DEC PAC I; CHAIR, DENTAL, WITH OPERATIVE UNIT

Model Number PAC 1 3420

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2021

Event Type  malfunction  

Event Description

During this patient¿s procedure (dental rehabilitation), the high speed drill quit working on cart.Everything was switched over to another cart, which also failed to work.Biomed called to come to the or asap 3 times.Through process of elimination, it was discovered the coupler in the hand piece needed replacement.Procedure then continued.Pt (child) had 45 minutes extra surgery time/anesthesia time).Manufacturer response for dental cart, (brand not provided) (per site reporter).Confirmed the connector was the issue.Mfg came on site to review cart to ensure it was good for patient use.

• Brand Name: A-DEC PAC I
• Type of Device: CHAIR, DENTAL, WITH OPERATIVE UNIT
• Manufacturer (Section D): A-DEC, INC.; 2601 crestview drive; newberg OR 97132
• MDR Report Key: 13391967
• MDR Text Key: 284704892
• Report Number: 13391967
• Device Sequence Number: 1
• Product Code: KLC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PAC 1 3420
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1