MAUDE Adverse Event Report: JOERNS HEALTHCARE DOLPHIN FIS MATTRESS; PATIENT AIR MATTRESS

Model Number DLPH-000000DMJ-CU

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2018

Event Type  malfunction  

Event Description

It was reported to the manufacturer by the end user, per the end user, "dolphin pump alarming "fault".Pump was replaced by (b)(4).New pump them also alarmed "fault" and the mattress would not inflate, leaving patient lying on hard surface of bed frame for approximately 2 hours and at high risk of pressure related skin injury." upon speaking with uhs, the product involved was removed from the facility and did not cause harm to the patient.(b)(4) and (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: DOLPHIN FIS MATTRESS
• Type of Device: PATIENT AIR MATTRESS
• 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 ; avenida pedro hinojosa no.26; ciudad industrial; matamoros, tamaulipas 87499 ; MX 87499
• MDR Report Key: 8178955
• MDR Text Key: 131744511
• Report Number: 3009402404-2018-00087
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2018

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: Health Professional
• Device Model Number: DLPH-000000DMJ-CU
• Device Catalogue Number: DLPH-000000DMJ-CU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/19/2018
• 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 Age: 28 YR