MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P7500A001677

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

The customer initially reported experiencing pressure injuries with the use of the hillrom progressa bed.Additional details received found that there was no patient injury associated with this device.The progressa® bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa® bed is intended to provide a patient support to be used in health care environments.The progressa® bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The progressa® bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.The intended users of this product are healthcare employees who have been trained to use the product,and who have the physical strength and cognitive skills to operate and control the product.The functionality of this device could not be confirmed, as this investigation is still ongoing.However when any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

The customer initially reported experiencing pressure injuries with the use of the hillrom progressa bed.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #c-(b)(4).

Manufacturer Narrative

The customer initially reported experiencing pressure injuries with the use of the hillrom progressa bed.Additional details received found that there was no patient injury associated with this device.The progressa® bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa® bed is intended to provide a patient support to be used in health care environments.The progressa® bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The progressa® bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.The intended users of this product are healthcare employees who have been trained to use the product, and who have the physical strength and cognitive skills to operate and control the product.An inspection of the bed by a hillrom technician found that the bed was functioning correctly and in accordance with the technical manual.All values are within the ranges of the technical documentation.The pressures measured were in compliance with the expectations.No malfunction, the bed was performing within specifications.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The hrc technician investigated the device thoroughly and could not replicate the reported issue.No malfunction.There was no patient involvement or serious incident reported and should this incident recur, it is unlikely to cause or contribute to a serious incident for the reasons stated above.Therefore, hillrom does not consider this complaint reportable.Based on this information, no further action is required.

Event Description

The customer initially reported experiencing pressure injuries with the use of the hillrom progressa bed.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: PROGRESSA FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13370246
• MDR Text Key: 286647518
• Report Number: 1824206-2022-00038
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761000100
• UDI-Public: 010088776100010011211030
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A001677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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