MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. CAREVO

Model Number BAC1111-01

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 12/03/2014

Event Type  malfunction  

Event Description

It was reported by the company representative that the castor fell during the shower, this happened because by abnormal wear of the wheel.

Manufacturer Narrative

(b)(4).Additional information will be provided upon conclusion of the investigation.

• Brand Name: CAREVO
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4384092
• MDR Text Key: 5265072
• Report Number: 3007420694-2014-00150
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/23/2014,12/03/2014

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: BAC1111-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2014
• Distributor Facility Aware Date: 12/03/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/23/2014
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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