MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. SPIRIT SELECT

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Add'l info will be provided upon conclusion of the investigation.

• Brand Name: SPIRIT SELECT
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore rd; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4619916
• MDR Text Key: 5700764
• Report Number: 3009988881-2015-00015
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Remedial Action: Inspection
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/21/2015
• Initial Date FDA Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1