MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number PXA001DAR

Device Problems Folded (2630); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016 arjohuntleigh received an information about an event which occurred with the involvement of auto logic system.It was indicated that a patient who was at a high risk of developing pressure ulcers was laying on the mattress which top cover was creating folds under patient's bottom (the most vulnerable area).As a result patient developed a pressure ulcer and red marks reflecting the folds.The severity of pressure ulcer is currently unknown.It was also indicated that the facility staff made attempts to stretch and adjust the cover, however, patient's skin was too fragile and the injury kept escalating.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Following the information reported, it was indicated that a patient who was at a high risk of developing pressure ulcers was laying on the mattress which top cover was creating folds under patient's bottom (the most vulnerable area).Initially, it was suspected that the patient has developed a pressure ulcer of unknown stage and redness, which determined a reportability decision.In the due course, it was confirmed that this particular patient has only developed red marks reflecting the folds when using auto logic mattress.The problem was noticed by caregivers who observed the effects on patient's skin and attempted to adjust the cover in order to achieve a better pressure relief appropriately to patient's condition.As the skin was observed too fragile and the redness was not getting healed, the patient was removed from the mattress.No serious injury was created.Arjohuntleigh was also informed that the transfer of patient to another mattress did not heal patient's outcome.When the red mark was detected and patient was moved to another (non-arjohuntleigh) mattress, indicated as 'better suited for the vulnerable patients', the pressure ulcer escalated.The stage of escalated pressure ulcer was unknown.It was indicated that the manufacturer of the other involved mattress is a care of (b)(4).When reviewing similar reportable events on auto logic system, it was possible to determine that this is the first complaint presenting a scenario in which patient's condition which the patient has received an injury due to folded mattress cover.The occurrence rate observed for this failure mode is currently considered to be very low.The top cover of involved mattress was not evaluated by arjohuntleigh but according to the comments of facility staff, when compared with a brand new top cover from the stock, it did not reveal any noticeable differences in material structure or visual performance.There is a high probability that the mattress did not malfunction and was up to specification when the event occurred.Following the information gathered, the patient's condition is considered to have contributed to the outcome of this event.It is believed that folds generated by the cover cannot solely result in a serious injury if combined with an appropriately implemented program of skin care and patient's repositioning.An alternating therapy provided by auto logic is believed to provide a significant degree of pressure relief.This statement was confirmed by the scenario of reported event - the outcome was observed at the very early stage (skin redness) and the product was no longer used with this patient since the detection.This event reported to competent authorities due to the initial lack of information regarding the severity of patient's outcome.However, basing on the investigation conclusion and along with new information received, arjohuntleigh no longer find this event to compromise patient's or users safety.It has been established that the auto logic system was in use for a patient therapy at the time of the event but from our review we did not find any direct indication that it contributed to the outcome of the event.Based on the above, the device was found not to have malfunctioned (was performing up to the specification) when the event took place.Arjohuntleigh no longer perceive this event to be reportable.

• Brand Name: AUTO LOGIC
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, PL-62 052; PL PL-62052
• Manufacturer Contact: kinga stolinska ; ks. wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 698 282 46
• MDR Report Key: 6210943
• MDR Text Key: 63627869
• Report Number: 3007420694-2016-00265
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

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 Caregivers
• Device Model Number: PXA001DAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2017
• Distributor Facility Aware Date: 11/29/2016
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2017
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• 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