MAUDE Adverse Event Report: HILL-ROM MEXICO CENTRELLA 36" WIDE W/O X-RAY; BED, FLOTATION THERAPY, POWERED

Model Number P7923A03

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/06/2022

Event Type  Injury  

Event Description

The customer alleged that the top cover of the pro+ mattress was delaminating, and the particles of the cover were becoming, ¿embedded in¿ and ¿found on¿ patient¿s skin with nurses using alcohol swabs to remove them.There was no allegation of patient injury reported from this incident.The customer states that during a patient consult from an infection prevention physician.The bed was located at the account.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

The customer alleged that the top cover of the pro+ mattress was delaminating, and the particles of the cover were becoming, ¿embedded in¿ and ¿found on¿ patient¿s skin with nurses using alcohol swabs to remove them.There was no allegation of patient injury reported from this incident.The customer states that during a patient consult from an infection prevention physician, ¿the patient was laying directly on the pro+ mattress cover with no sheet on the mattress.¿ communication between the customer and the hillrom account executive determined delamination of ticking as due to non-approved device ifu disinfectant on the cover, however no further details of the cleaner type or process were disclosed.The customer is currently in the process of switching to an approved cleaner/disinfectant.Follow-up attempts were made with the customer, however, they have not provide any further details of the initial alleged harm/injury associated with the device, including: number of patients with involved injuries, date of injures, specific injury type, medical intervention provided, length of delay allegations, device serial numbers associated with each mattress cover and patient, and additional patient information including admitting diagnoses, past medical history, gender, age and weight, and each patient¿s outcome.Additional questions to the customer included: device serial number of the pro+ mattress, mattress cover, confirmation of bed type and serial number the pro+ mattress and mattress cover were used on, and facility cleaning and disinfecting process used on the pro+ mattress cover.Hillrom has received no information back on the above.The hillrom pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.Approved device cleaners/disinfectants for use and the associated contact time for disinfection are in the ifu, table 1, page 86.Additionally, the device ifu states the following on disinfection: with a new or clean wiping cloth soaked in an approved cleaner/disinfectant, use light pressure to wipe all exterior surfaces of the mattress previously cleaned.Make sure all surfaces remain wet with the cleaner/disinfectant for the specified contact time.Re-wet surfaces with a new wiping cloth, as necessary.The device ifu states the following on maintenance: examine the following for damage: top mattress cover, bottom mattress cover, zipper closure.Replace any damaged components.Areas of discoloration are a sign of fluid ingress.To help prevent injury and/or equipment damage, obey these warnings: only facility-authorized persons should service the pro+ mattress.Do not use a mattress that has a damaged cover or mattress core assembly.The ifu states the following on device expected life: replace the top cover every 2 years.Look at the product information label to determine the age of the top cover.The label is on the right side of the cover, near the foot end.Make sure the life expectancy of the top cover and mattress core assembly have not been exceeded.If the top cover has not exceeded its life expectancy, examine the outer cover for signs of abrasion, cuts, tears, and fluid ingress.If the top cover is compromised or fluid ingress is evident¿evaluate the top cover for additional contamination.If contamination is localized, replace the component(s) affected.If the component is not replaceable, discard and replace the top cover.Inspection has not occurred due to the customer not providing any record of what pro+ mattress, mattress cover, or bed type that was involved in this incident.If any new relevant information is received the complaint will be addressed accordingly.The event was likely due to user error as it was determined delamination of ticking was a result of non-approved disinfectant use on the device.Additionally, the customer noted that there was no sheet on the mattress; therefore, the patient¿s skin was in direct contact with the mattress ticking and disinfectant used on the device.Procedures for prevention of this type of event are outlined per the ifu as noted above.Due to limited information provided on particles of the cover being, ¿embedded into the patient¿s skin,¿ permanent impairment of a body function or permanent damage to a body structure and/or medical intervention (serious injury) cannot be ruled out.Based on this information, no further action is required.

• Brand Name: CENTRELLA 36" WIDE W/O X-RAY
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM MEXICO; ave.del telefono no. 200 col. huinala; apodaca, nuevo leon
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15699976
• MDR Text Key: 302709575
• Report Number: 3006697241-2022-00072
• Device Sequence Number: 1
• Product Code: IOQ
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2022

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 Model Number: P7923A03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/31/2022
• 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