MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTORESTMI; NONE

Model Number 8259965-R

Device Problem Insufficient Information (3190)

Patient Problem Bacterial Infection (1735)

Event Type  Other  

Event Description

The following was reported arjohuntleigh by the facility: a swab test was done on the bed and cultured.The culture produced the bacteria acinetobacter baumannii.No further info is known at this time.When the investigation is concluded the results will be submitted in a supplemental report.This is being reported with an abundance of caution due to the bacteria cultured may possibly contribute to serious injury or death if exposed to a compromised patient.

Manufacturer Narrative

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

• Brand Name: ROTORESTMI
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore road; suite 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 12625 wetmore road, ste 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3988083
• MDR Text Key: 17992286
• Report Number: 3010048749-2014-00078
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/04/2014

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?: Yes
• Device Operator: Other
• Device Model Number: 8259965-R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/1995
• 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