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

Model Number PXB005DAR

Device Problems Component Falling (1105); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016, arjohuntleigh employee who was performing service on auto logic mattress has noticed the malfunction of the cpr module on the serviced mattress - the cpr could not have been opened when trying to release the mechanism.The technician has replaced the cpr module and tested the mattress with a positive result.This repair was performed on the customer owned mattress - the device came back to arjohuntleigh for service with no indication from the customer regarding an inoperative cpr module.The circumstances of problem occurrence are unknown which does not allow to exclude a potential for a hazardous situation.No information about any injury was reported to arjohuntleigh.Unfortunately, the part was not kept for further evaluation.It was not possible to determine any additional symptoms of the malfunction, no cracks or material damages were indicated.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.Based on the information received by arjohuntleigh auto logic mattress was suspected to be involved in the potentially reportable event due an initial allegation from sales and service unit regarding the cpr module which was impossible to be activated.It was initially unknown, whether the claimed symptom was discovered at the customer facility or during the service.No adverse consequences occurred, no serious injury to the patient or user has occurred.When reviewing similar reportable events, we have found no other records presenting a similar scenario to the one investigated.It has been established that auto logic mattress (which was more than 6 years old) was found to be faulty (not performing up to the specification) with no indication for any particular component's failure.According to the technician's report there was no customer allegation regarding this system.We may assume that the cpr failure was discovered by the technician during routine maintenance.As a result of general service performed on the mattress, the cpr module required replacement, which was supported by the comment: "the cpr did not work".Unfortunately, the part was discarded after the service - it was not possible to conduct any further evaluation at the manufacturing site.It is worth to mention that the review of service history revealed no records of previous cpr module replacements which may suggest that it was the originally fitted module which failed.Along with new information received it has been indicated that the device was in very bad condition when found.This allows to conclude that the user who is obliged to visually inspect the system before and during the therapy acted properly and withdrawn the mattress from use.Indicated condition of the component could have contributed to the internal failure and impossibility to activate the module.In the course of investigation it was not possible to establish the exact root cause of the failure, however there were a few likely scenarios concluded: a poor visual condition of the cpr module has made the user to withdraw the system from use and quarantine it until the service was performed.The symptom of activation problem was not reported by the customer which supports the scenario that it did not occur during the therapy/ at the customer's side.Accidental damage noticed by the customer.The module might have been involved in an unexpected damage (rough handling, hitting) which made the user check the functionality of the module and withdraw it.Accidental damage noticed by the service.The cpr module may have lost its functionality during transportation process to the service center due to a poor condition of the component and external factors occurring - the service staff was the first user to observe the reported symptom and acted properly by replacing the part.Possible sequence of events presented above seems to be the most probable and in line with the event description.None of the above present a scenario compromises patient's or caregiver's safety.Basing on the information available, it was found that the event was most likely caused by use error - accidental mechanical damage.However, the deterioration of materials during the years of usage may have contributed to the outcome of claimed failure.Although no serious injury took place, we have reported this event to competent authorities in abundance of caution, due to a very limited information which could have excluded the potential for a hazardous situation occurrence.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 was possible to establish that auto logic system was not in use for a patient therapy at the time of the event.However, the mattress was found to have malfunctioned (not performing up to the specification).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: 6180282
• MDR Text Key: 62716269
• Report Number: 3007420694-2016-00257
• Device Sequence Number: 1
• Product Code: FNM
• 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
• Type of Report: Initial,Followup
• Report Date: 01/14/2017,11/18/2016

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: No Information
• Device Model Number: PXB005DAR
• 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: 01/14/2017
• Distributor Facility Aware Date: 11/18/2016
• Device Age: 6 YR
• Event Location: Other
• Date Report to Manufacturer: 01/14/2017
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2010
• 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