MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ATMOSAIR 9000A; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Malposition of Device (2616); Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion is not available yet.A follow-up report will be provided upon investigation completion.

Event Description

A customer reported that the patient who was placed on the non-arjo bed with the arjo atmosair 9000a mattress was found by the caregiver with two-thirds of his body under the mattress.No injuries were sustained.

Event Description

The patient, who was very mobile (was able to get out of bed at night by himself) and could suffer from delusions, was found with two-thirds of his body under the atmosair 9000a mattress.The mattress was placed on a non-arjo posey bed.The patient did not sustain any injury.The caregivers took the mattress away from the patient and released him.

Manufacturer Narrative

It was determined that the hospital employee accidentally accepted the atmosair 9000a mattress delivery, which was intended to be used for another patient with the same surname, and placed it on the posey bed.The posey bed is not intended to be used with this type of the mattress.Since it was confirmed that the mattress was erroneously placed by the hospital staff on the bed which is not intended for use with it, the root cause of the event was assessed as use error.The posey bed has its own incorporated mattress designed in the way that prevents patient from crawling underside and is not designed to be used with any other mattress.It was confirmed by the interviewee.The ifu for atmosair 9000a mattress 407384-ah provides the following information regarding the use of the mattress with the appropriate bed frame: ¿always use a standard healthcare bed frame with this mattress, with any safeguards or protocols that may be appropriate.Bed frame and side rails (if used) must be properly sized relative to the mattress to help minimize any gaps that might entrap a patient¿s head or body.It is recommended that bed and side rails (if used) comply with all applicable regulations and protocols.¿ at the time of the event the arjo device was in use with patient therefore it played a role in the reportable incident.The atmosair 9000a mattress did not show any deficiency at the time of the event.

• Brand Name: ATMOSAIR 9000A
• 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
• MDR Report Key: 11737167
• MDR Text Key: 251670234
• Report Number: 3007420694-2021-00060
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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: Lay User/Patient
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 92