MAUDE Adverse Event Report: DJO, LLC CHATTANOOGA; ADAPTA ADP300 BLK 28

Model Number ADP30000212FC

Device Problem Collapse (1099)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "the pedal has an issue with raising and lowering.Attempted to lower the head piece.The whole pin piece snapped off.Clinic indicates "one of the patients fell down.As far as we know, they were not hurt".Questionnaire not received from clinician and/or patient.Device not returned to manufacturer for evaluation.No indication event caused or contributed to serious injury, permanent impairment or death.

• Brand Name: CHATTANOOGA
• Type of Device: ADAPTA ADP300 BLK 28
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): CONTRACT INDUSRIAL TOOLING (CIT); 2351 production court; richmond IN 47374
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 5688603
• MDR Text Key: 46202820
• Report Number: 2020737-2016-00005
• Device Sequence Number: 1
• Product Code: ITH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ADP30000212FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other