MAUDE Adverse Event Report: COOLSYSTEMS, INC. (DBA GAME READY) GRPRO 2.1 AND STRAIGHT KNEE WRAP; COLD- AND INTERMITTENT COMPRESSION

Model Number 550500-03

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

Patient Problems Scarring (2061); Superficial (First Degree) Burn (2685)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

Coolsystems inc.Became aware of the incident via email sent by (b)(6) distributor, restore motion, on (b)(6) 2019.The (b)(6) contacted coolsystems, inc.'s customer service stating that an incident occurred with a patient in (b)(6) of 2018 who is claiming that the game ready caused a burn on his shin and that they are now doing "a series of tests to prove that it is not possible".They asked if coolsystems, inc.Has a specific way of testing units and what the coldest possible temperature is.They stated the unit was removed from their rental pool and arrangements were made to ship the unit back to game ready.Coolsystems, inc.Began the investigation by interviewing the (b)(6).The (b)(6) stated that the patient did see a physician for the alleged injury and provided the patient contact information.They also provided email communications between the (b)(6) and the patient that stated that he used the game ready system immediately after surgery and followed the protocol provided by the physician of 30 minutes on / 30 minutes off with full cold (34 degrees), low compression (5-15mmhg), wearing a stockinet.He followed this protocol through post-op day 3 at around noon when he felt a sharp pain in his shin since the "anesthesia" just wore off.He pulled down the stockinet and noticed a "massive burn area" on his shin.The patient immediately stopped using the device and called his doctor to make an appointment for friday, (b)(6) 2018.The patient called the (b)(6) and coordinated to have the unit picked-up and was advised that the patient would be refunded.Coolsystems, inc.Interviewed the patient, on (b)(6) 2019.The patient stated that he is no longer receiving medical care and is currently experiencing scarring and that the physician agrees the game ready system may have attributed to the alleged injury.The patient confirmed his surgery date of (b)(6) 2018 and used the game ready system with a straight knee wrap.It was also stated that the patient took pain medication for surgery for the first 36 hours afterwards, but does not remember what kind of medication.The device was confirmed to be received on august 9, 2019 and the plans for engineering to conduct an engineering inspection and test for the unit is ongoing.

Event Description

Patient had knee surgery on (b)(6) 2018 and used the game ready immediately after surgery that day.He was told by the doctor to follow a 30 minutes on / 30 minutes off protocol with full cold (34 degrees), low compression (5-15mmhg), wearing a stockinet.Patient took unspecified pain medications 36 hours after surgery.On post op day 3 patient reports experiencing a sharp pain on his shin and also presents with a pronounced area of redness on his shin.He states the pain medications had worn off at this point.Patient quits using the game ready and visits the doctor on post op day 4.The patient states that the doctor is concerned about the burn area on his shin to stop using the game ready and that the game ready may have contributed to the burn.Coolsystems, inc.Was notified of this alleged injury on (b)(6) 2019 by the distributor, who was conducting an investigation to determine if the game ready could have contributed to the alleged injury.Coolsystems, inc.Interviewed the patient on (b)(6) 2019 and the patient reported that he's no longer receiving care for the alleged injury and stated that he is experiencing scarring.

Manufacturer Narrative

Activity for 30 days after the initial submission of the adverse event has included engineering testing and visual inspection for the device in question and has been formally documented in an engineering test report (etr) #2706 - grpro 2.1 issue investigation.An assembled unit tester (aut) test was conducted to assess the performance of the device.The measurements for the fluid pressure (psi), fluid flow (ml/m), and temperature (°f) were all within normal operating range.Similarly, the air pressure (mmhg) measurements were found to be normal.The aut test results confirm the device in question operated normally without any malfunctions.The visual inspection revealed the system looked clean and in good working condition.There were no misconnections within the system internals or externals.Engineering assessment concludes the device in question is operating normally.

• Brand Name: GRPRO 2.1 AND STRAIGHT KNEE WRAP
• Type of Device: COLD- AND INTERMITTENT COMPRESSION
• Manufacturer (Section D): COOLSYSTEMS, INC. (DBA GAME READY); 1800 sutter street; suite 500; concord CA 94520
• MDR Report Key: 8897617
• MDR Text Key: 155487946
• Report Number: 2954777-2019-00002
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 00812120000514
• UDI-Public: 00812120000514
• Combination Product (y/n): N
• PMA/PMN Number: K072620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 550500-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability