MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. SPIRIT SELECT

Model Number CHGSS1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Initially, it has been claimed that the bed was ringing and was not locked.The pt had fallen out of the bed twice.It is unclear with the limited info provided if the pt sustained a serious injury in either of the falls.

Manufacturer Narrative

(b)(4).As a consequence of issues with the integration of the former kci rental business into arjohuntleigh and challenges from i.E.It perspective we were forced to a more manual process to screen service data for complaints.We have realized that this process did not detect all complaints and that arjohuntleigh have failed to get them all timely into our complaint handling system.Unfortunately, as a result of a retrospective review after this finding we have identified this reportable complaint that is filed late.As a consequence of te complaint being old we have limited info on the event while additional effort to obtain data has been performed.We will continue our efforts to complete this investigation.A capa has been initiated to document the efforts to complete investigations, and implement corrections and corrective actions.Additional info will be provided upon conclusion of the investigation.

• Brand Name: SPIRIT SELECT
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout dr; san antonio TX 78219
• 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: 4652097
• MDR Text Key: 18778886
• Report Number: 3009988881-2015-00025
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CHGSS1
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: No
• 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