MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. SPIRIT SELECT; IKZ

Device Problem Device Handling Problem (3265)

Patient Problem Death (1802)

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).The bed was ordered by the facility (#(b)(4)) and the rental start date was june 23rd 2016.According to the complaint description the medical staff experienced a problem with raising the bed during the patient coding.Before and after the rental period with this customer, the bed was comprehensively tested and no anomalies/malfunctions were found that could contribute to such allegation.The spirit select bed frame is equipped with 3 controllers that enable to bed to be elevated (hi/lo).The user manual (1-70-001 rev l) in point 3.3.1 bed elevation - hi-lo operation states as follows: to raise the bed, press the bed up arrow on the footboard staff control, the rail staff controls, or on the pendant.Release the button when the desired elevation has been achieved.To lower the bed, press the bed down arrow on the footboard staff control, the rail staff controls, or on the pendant.Release the button when the desired elevation has been achieved.It remains unknown which controller was used to elevate the bed.Furthermore, the bed is also equipped with patient lock-out function which restrict the patient from initiating head, knee, and bed motion from the side rail controls or the pendant (if equipped).The degree of restriction depends on the lock-out option selected.Additional option is "master lock-out" which completely restrict access to all bed functions (except the electronic cpr function) from all control locations (staff and patient controls.Relating to this functionality, it remains unknown whether the bed was locked prior the event occurrence - and it also remains unknown if before the intention to move the bed the controllers were unlocked.Due to the limited nature of the information we were able to receive -despite our best efforts- the root cause remains unknown, however since the bed was up to its specification pre and post placement it may be suggested that the bed operation by the hospital staff in the emergency situation during the patient coding, was what contributed to problems with elevating the bed to the higher position.In addition it needs to be emphasized that the level of the bed platform has no impact on the effectiveness of the cpr performance (in contrary to the backrest position).The lack of ability to position the bed on a different height may cause an inconvenient position for a medical staff however does not affect the cpr efficiency.Based on the investigation results, the device was being used for patient treatment during the event occurrence and was confirmed to be up to its specification.It did play the role in the event as it was present during the patient coding however it does not seem in any way to contribute to the patient outcome, which was also confirmed by hospital representative.The event is being reported purely due to our device's presence during the event.

Event Description

On 28th june 2016, arjohuntleigh has been contacted by representative of the (b)(6) hospitals icu (mrs.(b)(6)) to gain additional information about the spirit select rental bed that was ordered for a patient.It has been communicated that the patient coded on the bed and the hospital staff was unable to raise the bed to a higher position.Arjohuntleigh us asked whether this was something wrong with the bed or rather the staff handling, however the caller did not know that information.The caller was interested to gain the information about the date of the bed delivery which was 23rd june 2016.The caller did not know about the patient condition and the health state during the phone call.She stated she was asked to make an initial call on a request from risk management team.On (b)(6) 2016, arjohuntleigh complaint handler was informed that "the patient expired but had nothing to do with the bed, she stated that the patient was not doing well".

• Brand Name: SPIRIT SELECT
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; , tx 78219, u; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 4958 stout drive; , tx 78219, u; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5826451
• MDR Text Key: 50565115
• Report Number: 3007420694-2016-00158
• 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: company representative,consum
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/27/2016,06/28/2016

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: Health Professional
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2016
• Distributor Facility Aware Date: 06/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death