MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-13 for RELIANCE MEDICAL PRODUCTS, INC 6200L manufactured by Reliance Medical Products, Inc..
[146362381]
Reliance medical received a complaint alleging a #18 headrest failed on a 6200l model chair. No series injury took place. (b)(6) medical center biomed stated that when pressure is applied the headrest it may collapse backwards. Reliance technical service followed up and in-serviced the customer on proper instructions to ensure the headrest is locked. Reliance technician explained the no. 18 headrest is designed so it can be operated with just one hand. To unlock, squeeze the clear plastic actuator into lock housing. This will allow both pivots of the articulating arm to rotate so the headrest can be moved to a new desired position. Once in the new position, release the actuator. Make sure the actuator expands to its original position fully exposing black dot on handle to insure a positive lock. The headrest pad is free to rotate at all times. The customer disposed of the headrest and was unable to provide the headrest back to reliance for further investigation. Reliance is unable to confirm the device failed to meet its specifications and reporting on an alleged malfunction. This complaint will be logged as complaint #(b)(4). The customer has replaced the 6200l model chair with fx920l. The fx920l functions as designed.
Patient Sequence No: 1, Text Type: N, H10
[146362382]
Reliance medical received a complaint alleging a #18 headrest failed and a patient experienced whiplash. Reliance followed up concerning the allegation of whiplash and the customer did not provide the necessary information to determine the severity of harm of the alleged injury. Reliance does not consider this a serious injury. If any new additional relevant information is identified, the injury will be characterized accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523545-2019-00001 |
| MDR Report Key | 8603307 |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-13 |
| Date of Event | 2018-12-31 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2019-05-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN CUMMINGS |
| Manufacturer Street | 3535 KINGS MILLS ROAD |
| Manufacturer City | MASON OH 450402303 |
| Manufacturer Country | US |
| Manufacturer Postal | 450402303 |
| Manufacturer Phone | 5133983937 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RELIANCE MEDICAL PRODUCTS, INC |
| Generic Name | MODEL 6200 EXAMINATION AND TREATMENT CHAIR |
| Product Code | HME |
| Date Received | 2019-05-13 |
| Model Number | 6200L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RELIANCE MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 3535 KINGS MILLS ROAD MASON OH 450402303 US 450402303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-13 |