MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. THERAREST

Model Number 407010-R

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

Patient Problems Death (1802); Physical Entrapment (2327)

Event Date 03/16/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported to the arjohuntleigh representative that the resident was found in the morning with no vital signs, with her face, facing into the mattress.The side of her head, in the area close to back of her ear, was caught on the side rail.Her arms were underneath the bed, and from the waist down with right side hip was on the floor.Sheets were around her.There were no other signs of trauma.As indicated by the customer the arjohuntleigh therarest mattress was in use with non-arjohuntleigh bed frame.

Manufacturer Narrative

(b)(4).Arjohuntleigh received information regarding adverse event where the patient was claimed to be found with no vital signs, facing towards the mattress and entrapped between the bed side rails and the mattress.The patient's arms were underneath the bed, and from the waist down with right side hip was on the floor.Following details received, we can determine that the patient entrapped in zone 3 according to appendix e of fda guidance - drawings of potential entrapment in hospital beds; the entrapment between the rail and the mattress.Performed review of similar complaints from the past allowed us to establish that this incident is a single, isolated case.The arjohuntleigh mattress - therarest has been used with a non-arjohuntleigh bed frame, manufactured by joerns company.The facility staff stated that they do not see a connection between mattress and the patient's unfortunate death.With the limited information available to us and fact, that the event was not witnessed we are not able to fully determine the circumstances which have led to the entrapment occurrence.There are several potential causes (mattress migrated not being properly attached to the bed frame, or incompatible with the size of the bed) however none of these factors could have been confirmed during the investigation course.According to the facility staff, this was an unfortunate incident and did not see any connection with the arjohuntleigh mattress which have been used.It is worth to be noted that the instruction for use (ifu) supplied with therarest mattress (p/n 205559-ah rev.C) includes crucial safety information regarding use and correct selection of the bed frame: "bed frame - always use a standard healthcare bed frame with safeguards or protocols that may be appropriate.It is recommended that bed and side rails (if use) comply with the hospital bed system dimensional and assessment guidance to reduce entrapment, march 2006.Frame and side rails must be properly sized relative to the mattress to help minimize any gaps that might entrap a patient's head or body.Caution: to help prevent inadvertent bed exit or falls manufacturer recommends ensuring the distance between top of side rails and top of mattress is approx.4.5 inches.Consider individual patient size, position and patient condition in assessing fall risk." it is worth to mention that the review performed of same or similar complaints for therarest mattress allowed us to establish that this incident was a single, isolated case.In summary, the arjohuntleigh mattress played a role in the event as it was used for the patient treatment when the event occurrence.Based on the limited nature of the received information we were not able to establish an actual circumstances that have led to the entrapment occurrence, although we were able to exclude a mattress malfunction, thus we conclude that it appears unlikely it caused the patient's unfortunate death.Due to the fact that arjohuntleigh product has been directly involved in the event we report it based on patient outcome and to be transparent in our reporting approach.

• Brand Name: THERAREST
• Type of Device: THERAREST
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5547234
• MDR Text Key: 41852460
• Report Number: 3007420694-2016-00043
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 06/15/2016,03/22/2016

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: Lay User/Patient
• Device Model Number: 407010-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2016
• Distributor Facility Aware Date: 03/22/2016
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/15/2016
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 95 YR
• Patient Weight: 64