MAUDE Adverse Event Report: DJO LLC CPM OPTIFLEX; EXERCISER, POWERED

Model Number 2029

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient allegedly had to undergo a second surgery on her shoulder after utilizing the continuous passive motion (cpm) machine, setup in her home by the supplier referred by her physician.The investigation is ongoing and djo will provide a supplemental report upon completion.

Event Description

It was reported that the patient allegedly had to undergo a second surgery on her shoulder after utilizing the continuous passive motion (cpm) machine, setup in her home by the supplier referred by her physician.

• Brand Name: CPM OPTIFLEX
• Type of Device: EXERCISER, POWERED
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el flirdo; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision street; vista, CA 92081 ; 5128346301
• MDR Report Key: 11424988
• MDR Text Key: 247724641
• Report Number: 9616086-2021-00003
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2029
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Date Manufacturer Received: 02/03/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other