N
Patient 1
(B)(4). (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.
MAUDE MDR 6776353
- MDR report key
- 6776353
- Report number
- 9681684-2017-00059
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-07-07
- Date received
- 2017-08-09
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. KINGA STOLINSKA
- Address
- UL. KS. WAWRZYNIAKA 2 KOMORNIKI, 62-05 PL
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STEDY | CHAIR, WITH CASTERS | ARJO MED. AB LTD | INM | NTA1000 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-08-09 | 0 | 1. O |
Event Narratives#
D
Patient 1
A CUSTOMER REPORTED THAT A FEMALE PATIENT AFTER DELIVERY WAS TRANSFERRED TO THE BATHROOM USING A FLOOR LIFT. AT THAT MOMENT IT WAS STATED THAT THE PATIENT CONDITION WAS GOOD. ON A WAY BACK THE PATIENT LOST CONSCIOUSNESS WHILE ON STEADY AND DUE TO THE FACT THAT THE SEAT SECTION COULD NOT BE LIFTED AS A PATIENT BODY WEIGHT LAY ON IT, THE PATIENT HAD TO BE LIFTED OVER THE DEVICE TO PLACE ON A BED. WHILE LIFTING THE PATIENT MANUALLY A CAREGIVER FELT PAIN IN A BACK DESCRIBED AS "ZING". THE CAREGIVER RETURNED TO FULL DUTY, NO MEDICAL INTERVENTION WAS REQUIRED. SUDDEN WEAKNESS OF A PATIENT WAS CAUSED BY A "VASOVAGAL RESPONSE TO HER BODY ADJUSTING TO THE BLOODLOSS AFTER CHILDBIRTH." THERE WAS NOT A SERIOUS INJURY IN RELATION TO THIS EVENT.