FDA Adverse Event
Malfunction
Summary report: N
KEEPSAFE FALL MONITOR
MDR report key: 1893984
·
Received November 3, 2010
Report
- Report Number
- 2020362-2010-00322
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Report Date
- September 21, 2010
- Manufacturer
- DONGGUAN POSEY MEDICAL DEVICE LTD.
- Product Code
- KMI
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS POWER BUT NO ALARM TONE. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER INITIALLY DID NOT PROVIDE A REASON FOR THE RETURN OF THE ALARM. THERE WAS NO PATIENT INCIDENT OR INJURY. THE PRODUCT WAS RECEIVED WITH A NOTE ON IT STATING "NO POWER". INSPECTION OF THE PRODUCT SHOWS THAT THE ALARM POWERS ON, BUT THERE IS NO ALARM TONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KEEPSAFE FALL MONITOR | KMI | DONGGUAN POSEY MEDICAL DEVICE LTD. | 8350 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | SQUARE CHAIR SENSOR PAD, MODEL: 8308, LOT NUM: NI |