MAUDE Adverse Event Report: HILL-ROM BATESVILLE SENTRY 1200 MATTRESS; BED, FLOTATION THERAPY, POWERED

Model Number SENTRY1200MATT

Device Problem Inflation Problem (1310)

Patient Problem Damage to Ligament(s) (1952)

Event Date 09/02/2021

Event Type  Injury  

Manufacturer Narrative

It was initially reported during follow-up on (b)(4) on (b)(6) 2021, that the caregiver injured her arm caused by difficulty repositioning her patient who was ¿sinking¿ in the sentry 1200 mattress as a result of an alleged malfunction.The caregiver reported the bed was alarming and the screen displayed alternating pressure/weight.At the time of the initial call, the reported issue with the mattress had been occurring for approximately four weeks.The sentry 1200la pressure-relief mattress system is a microprocessor-controlled therapeutic pressure-relief mattress system for use in a controlled environment, free from extreme temperatures, high humidity, or excessive amounts of airborne dust or smoke.Follow-up was conducted with the caregiver on (b)(6) 2021.The caregiver clarified she injured her right shoulder and saw her pcp for the injury.An mri was performed, which revealed torn ligaments or muscles.The caregiver¿s pcp referred her to an orthopedic surgeon and an appointment was scheduled on (b)(6) 2021, but she missed the appointment and had not yet contacted the surgeon¿s office to reschedule.The caregiver stated she was taking tylenol as needed for pain and using a topical analgesic cream at bedtime.Additional follow up attempts were performed to obtain information on the outcome of the orthopedic consultation, but no further information could be obtained as the reporter did not return hillrom¿s calls.The hillrom service technician determined the blower for the mattress was no longer functioning and inflating the mattress.It was also determined that the sentry 1200 bed is no longer produced, and parts for the purpose of the repair are not available.However, the bed operated as intended and provided appropriate notification to the user.The reported injury can be attributed to the failure of the user to respond to the notification and resolve the issue.Hillrom considers this event a reportable serious injury as muscle and/or ligament tears generally require treatment, whether surgical or non-surgical, to prevent worsening of the injury or permanent damage.As no serial number was provided for this bed, a search of the hillrom maintenance records for any hillrom performed preventative maintenance on this bed was unable to be completed.It is unknown if the facility performs preventative maintenance on their beds.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating hat the caregiver injured her arm caused by difficulty repositioning her patient who was ¿sinking¿ in the sentry 1200 mattress as a result of mattress not inflating.The caregiver reported the bed was alarming and the screen displayed ¿alternating pressure/weight¿.Patient injury was reported at the time of the initial event.The bed was located at the patient's home.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: SENTRY 1200 MATTRESS
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 12542036
• MDR Text Key: 273630855
• Report Number: 1824206-2021-00485
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2021

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?: Yes
• Device Operator: No Information
• Device Model Number: SENTRY1200MATT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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