MAUDE Adverse Event Report: JOERNS HEALTHCARE P.R.O. MATT PLUS CONTROL UNIT; AIR MATTRESS CONTROL UNIT

Model Number PMP-CBC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 03/09/2019

Event Type  Injury  

Manufacturer Narrative

Information for the mattress involved in the incident: (b)(4).Operator of device: health professional.(b)(4).Date received by mfr: 03/28/2019.

Event Description

It was reported to the manufacturer by the end user, per the end user, "on saturday this patient fell from his bed and dislocated his hip".The patient was transported to the hospital for evaluation and his hip was dislocated.(b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation.As of this writing, the mattress and control unit have not been returned.

• Brand Name: P.R.O. MATT PLUS CONTROL UNIT
• Type of Device: AIR MATTRESS CONTROL UNIT
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: felicia banks ; 2100 design road; alington, TX 76014 ; 8008260270
• MDR Report Key: 8465834
• MDR Text Key: 140347192
• Report Number: 3009402404-2019-00018
• Device Sequence Number: 1
• Product Code: FNM
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PMP-CBC
• Device Catalogue Number: PMP-CBC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• 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): Hospitalization