MAUDE Adverse Event Report: PRIDE MOBILITY JAZZY 614 HD; POWERED WHEEL CHAIR

Model Number JAZZY 614 HD

Device Problem Device-Device Incompatibility (2919)

Patient Problem Physical Entrapment (2327)

Event Date 08/05/2015

Event Type  Injury  

Event Description

The decedent was in a jazzy 514 hd monitorized wheel chair when the tubing from his foley catheter became tightly entangled in the right side wheel axle.The decedent cried out for help and was pronounced dead at the scene.

• Brand Name: JAZZY 614 HD
• Type of Device: POWERED WHEEL CHAIR
• Manufacturer (Section D): PRIDE MOBILITY; exeter PA 18643
• MDR Report Key: 5045360
• MDR Text Key: 24769388
• Report Number: MW5055843
• Device Sequence Number: 1
• Product Code: ITI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY 614 HD
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 40 YR
• Patient Weight: 166